regulatory affairs director

Bristol Myers Squibb

<div><b>Working with Us</b><br>
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.<br>
<br>
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .<br>
<br>
<b>Description:</b> The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met. Individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.<br>
<br>
<b>Responsibilities include:</b><ul><li>
Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area</li><li>
Provides solution oriented and innovative advice to meet the Company's objectives and goals</li><li>
Provide strategic advice for the development of Office Of Prescription Drug Promotion advisory submissions and sub part e submissions</li><li>
Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances</li><li>
Ensure regulatory compliance with sub part e and 2253 regulations</li><li>
Lead training for Commercial teams on sub part e, 2253 regulations and FDA regulations on advertising and promotion</li><li>
Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice</li><li>
Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies</li><li>
Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance</li><li>
Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues</li><li>
Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based</li><li>
Provide input on process improvement and BMS guiding principles as needed</li><li>
Engages with colleagues within the department to help support them in their roles and development</li><li>
Provide direct management to individuals depending on assignment
</li><li>Proactively seeks opportunities to learn and develop leadership skills</li></ul><b>
Qualifications:</b><ul><li>
BS required; advanced degree preferred (MS, PhD, PharmD, JD)</li><li>
Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)</li><li>
Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)</li><li>
Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns</li><li>
Proven aptitude to analyze and interpret efficacy and safety data</li><li>
Experience communicating and negotiating with OPDP</li><li>
Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration</li><li>
Excellent verbal, communication, and presentation skills</li><li>
Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.</li></ul>
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
<br>
<br>
<b>Compensation Overview:</b><br>
<br>
Princeton - NJ - US: $173,350 - $210,058
<br>
<br>
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
<br>
<br>
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
<br>
<br>
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
<ul><li><b>Health Coverage:</b> Medical, pharmacy, dental, and vision care.</li><li>
<b>Wellbeing Support:</b> Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
</li><li><b>Financial Well-being and Protection:</b> 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
</li></ul><b>Work-life benefits include:
</b><br>
<br>
Paid Time Off
<ul><li>US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
</li><li>Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
</li></ul>Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
<br>
<br>
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.<br>
<br>
<ul><li><b>Eligibility Disclosure: </b>T he summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
</li></ul><br>
<b>Uniquely Interesting Work, Life-changing Careers</b><br>
With a single vision as inspiring as Transforming patients' lives through science&trade; , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.<br>
<br>
<b>On-site Protocol</b><br>
<br>
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
<br>
<br>
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
<br>
<br>
<b>Supporting People with Disabilities</b><br>
<br>
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
<br>
<br>
<b>Candidate Rights</b><br>
<br>
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
<br>
<br>
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/
<br>
<br>
<b>Data Protection</b><br>
<br>
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .<br>
<br>
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.<br>
<br>
If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.
<br>
<br>
R1600349 : Associate Director, Commercial Regulatory Affairs</div>

Associate Director, Commercial Regulatory Affairs

Fresenius Medical Care

<div></div><div><div><p>PURPOSE AND SCOPE:<br>
Interfaces with local government regulatory bodies, the FDA, foreign registrars, and regulatory groups as required for product registrations and compliance requirements. Directs and leads a staff of regulatory professionals and develops their expertise in the interpretation and application of appropriate regulations. Responds to FDA and district office requests, as deemed appropriate.</p><p>
PRINCIPAL DUTIES AND RESPONSIBILITIES:</p><ul><li>
Directs and controls the broad activities of Regulatory Affairs Devices through the interpretation, application, and implementation of company-wide policies and processes appropriate to the functional area.</li><li>
Functions as a strategic leader with broad-based knowledge in individual department, and strong knowledge of industry practices and business principles. Works on complex issues and abstract issues/situations where analysis of situations or data requires an in-depth knowledge of the company.</li><li>
Ensures that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods.</li><li>
Responsible for the development and implementation of clinical strategies.</li><li>
Oversees the preparation and submission of regulatory documentation to the FDA.</li><li>
Responsible for ensuring the quality, content and format or regulatory submissions.</li><li>
Serves as primary FDA contact for projects, as assigned.</li><li>
Interprets and advises on the application of industry regulations and the FDA review process.</li><li>
Fosters positive and effective working relationships between project team members and health authority reviewers.</li><li>
Coordinates and consults with other departments regarding the content, review and assembly of regulatory documentation.</li><li>
Manages regulatory projects and plans in accordance with project, department and corporate goals.</li><li>
Prepares internal teams for FDA meetings.</li><li>
Reviews and approves investigator site regulatory documents according to FDA requirements.</li><li>
Develops and coordinates simultaneous strategies/initiatives for direct departments, and contributes to the development of divisional/business unit strategies.</li><li>
Interprets and provides recommendations for change of company-wide policies and practices. Establishes policies appropriate for the function.</li><li>
Regularly interacts with executives, senior management, and/or major customers. Interactions frequently require special skills such as negotiating or influencing customers and/or senior level leaders in matters of significance to the organization.</li><li>
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.</li><li>
Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.</li><li>
Provides leadership, guidance, and coaching for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.</li><li>
Collaborate with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization.</li><li>
Interacts with all levels within the organization to manage functional area. Overall responsibility for hiring, coaching, and counseling employees, including performance reviews, disciplinary action and terminations.</li><li>
Assists with various projects as assigned.</li><li>
Other duties as assigned.</li></ul><p>
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.</p><p>
PHYSICAL DEMANDS AND WORKING CONDITIONS:<br>
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</p><p>
SUPERVISION:<br>
Responsible for the direct supervision of various levels of Regulatory Affairs Devices staff.</p><p>
EDUCATION:<br>
Bachelor&rsquo;s Degree required in Mechanical or Electrical Engineering or Life Science; Advanced Degree preferred.</p><p>
EXPERIENCE AND REQUIRED SKILLS:
</p><ul><li>12+ years of experience in a Medical Device manufacturing company; 5+ years of experience in a senior managerial/director level role. Experience in the Pharmaceutical manufacturing field in addition to Medical Device experience is preferred.</li><li>
Working knowledge of the U.S. Food Drug and Cosmetic Act, and all associated regulations, especially the FDA medical device product approval processes, FDA legislature/regulation, post market approval requirements, and Quality Systems Regulations.</li><li>
Working knowledge of Medical Device Directives regarding the same, as well as the current ISO 90200 Quality Systems Standards and AMI Standards. Knowledge of the Canadian Device and Drug approval process is a plus.</li><li>
Technical knowledge of Medical Devices used in dialysis and renal care.</li><li>
Demonstrated leadership ability with project teams and direct report employees.</li><li>
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.</li><li>
Ability to managed multiple and varied tasks; ability to re-prioritize projects on a consistent basis.</li><li>
Must be able to work cross functionally within the organization.</li><li>
Strong management skills with the ability to lead cohesive and productive teams; influencing skills.</li><li>
Excellent oral and written communication skills.</li></ul><p></p><p>
The rate of pay for this position will depend on the successful candidate&rsquo;s work location and qualifications, including relevant education, work experience, skills, and competencies.<br>
<br>
Rate: $XX - $XX<br>
<br>
Non-Bonus Eligible Positions: include language below.<br>
<br>
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.<br>
<br>
Bonus Eligible Positions &ndash; include language below.<br>
<br>
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance</p><p></p><p>
Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.</p></div><p><b>
EOE, disability/veterans</b></p></div>

Head of Regulatory Affairs North America

Custom Health

<div>Description:
<p><b>
About Custom Health</b></p><p>
Custom Health is a fully integrated health technology company delivering patient-centric healthcare as a service. Our mission is to transform the patient experience for individuals receiving care at home by improving health outcomes while reducing the total cost of care.</p><p>
Powered by a modern purpose-built technology platform, high-volume central fill pharmacy operations, and an integrated clinical care team, Custom Health delivers optimized and personalized care for patients in the home with precision and scale.</p><p>
Custom Health operates across the United States and Canada, supporting regulated healthcare services, pharmacy operations, digital health platforms, and medical device technologies.</p><p><b>
Position Overview</b></p><p>
The Chief Compliance &amp; Regulatory Officer (CCRO) is responsible for leading enterprise-wide compliance, regulatory affairs, and quality governance across Custom Health, Inc. and its subsidiaries.</p><p>
The CCRO establishes and maintains the company&rsquo;s global compliance framework, ensuring that all operations comply with applicable healthcare, pharmaceutical, medical device, privacy, and corporate governance regulations across jurisdictions in which the company operates.</p><p>
Reporting directly to the Chief Executive Officer, with a dotted-line reporting relationship to the Board of Directors through the Audit &amp; Compliance Committee, the CCRO serves as the independent executive authority responsible for regulatory compliance, ethics, and quality oversight.</p><p>
The role provides executive oversight of regulatory and quality systems supporting regulated healthcare services, digital health platforms, and medical device operations, ensuring compliance with U.S. FDA regulations, Health Canada requirements, ISO standards, and applicable global regulatory frameworks.</p><p>
The CCRO also supports public company governance obligations, including regulatory disclosure risk management, internal controls, and compliance oversight expected of a TSX-listed organization.</p><p><b>
Key Responsibilities</b></p><p>
Enterprise Compliance &amp; Ethics Governance:</p><ul><li>
Develop and maintain the enterprise-wide compliance and ethics program across Custom Health, Inc. and all subsidiaries.</li><li>
Establish governance structures, policies, and procedures supporting regulatory compliance, corporate integrity, and ethical conduct.</li><li>
Promote a culture of accountability, transparency, and compliance throughout the organization.</li><li>
Ensure compliance functions operate with appropriate independence from operational management.</li></ul><p>
Regulatory Affairs &amp; Medical Device Compliance:</p><ul><li>
Provide executive oversight for regulatory strategy and compliance related to medical devices, digital health technologies, and regulated healthcare services.</li><li>
Ensure compliance with U.S. FDA regulations (including 21 CFR Part 820 Quality System Regulation), Health Canada Medical Device Regulations, and other applicable international regulatory frameworks.</li><li>
Oversee regulatory submissions, approvals, certifications, and lifecycle management.</li><li>
Serve as executive liaison with regulatory agencies, notified bodies, and external auditors.</li></ul><p>
Quality Systems &amp; ISO Compliance:</p><ul><li>
Ensure implementation and continuous improvement of enterprise Quality Management Systems (QMS).</li><li>
Maintain compliance with ISO 13485 and other applicable quality and regulatory standards.</li><li>
Oversee quality governance related to product development, manufacturing, distribution, and post-market surveillance.</li><li>
Ensure corrective and preventive action (CAPA), complaint handling, and regulatory reporting processes are properly implemented.</li></ul><p>
Healthcare Compliance &amp; Privacy:</p><ul><li>
Ensure enterprise compliance with HIPAA, healthcare privacy regulations, and applicable federal and state healthcare laws.</li><li>
Maintain oversight of compliance with Stark Law, Anti-Kickback Statute, and healthcare fraud and abuse regulations.</li></ul><p>
Enterprise Risk &amp; Compliance Monitoring:</p><ul><li>
 Conduct enterprise compliance risk assessments and regulatory gap analyses.</li><li>
Identify, assess, and mitigate regulatory, operational, and reputational risks.</li><li>
Establish monitoring and auditing frameworks to ensure ongoing compliance.</li></ul><p>
Auditing, Investigations &amp; Corrective Actions:</p><ul><li>
Oversee internal compliance audits and regulatory readiness assessments.</li><li>
Lead investigations into potential compliance violations.</li><li>
Ensure implementation of corrective and preventive actions and regulatory remediation programs.</li></ul><p>
Compliance Training &amp; Code of Conduct:</p><ul><li>
Develop and maintain enterprise compliance education and training programs.</li><li>
Maintain the company&rsquo;s Code of Conduct and ethics reporting systems, including confidential reporting channels.</li><li>
Strategic Initiatives &amp; Mergers and Acquisitions</li><li>
Provide compliance and regulatory oversight for corporate strategy, partnerships, and acquisitions.</li><li>
Conduct regulatory and compliance due diligence for mergers and acquisitions.</li><li>
Ensure acquired entities are integrated into the enterprise compliance and quality framework.</li></ul><p>
Board Governance &amp; Public Company Compliance:</p><ul><li>
 Provide regular reports to the Board of Directors and Audit &amp; Compliance Committee regarding compliance program effectiveness.</li><li>
Report on regulatory developments, investigations, audit outcomes, and enterprise risk exposure.</li><li>
Support compliance with public company governance standards, disclosure controls, and regulatory reporting obligations.</li><li>
Ensure strong corporate governance practices aligned with TSX-listed company expectations.</li></ul>
Requirements:<p></p><p><b><br>
Qualifications</b></p><ul><li>
Bachelor&rsquo;s degree required with an advanced degree preferred (JD, Master&rsquo;s degree, or equivalent).</li><li>
Professional certification preferred (CHC, CCEP, RAC, or equivalent).</li><li>
15+ years of senior leadership experience in healthcare compliance, regulatory affairs, or quality systems.</li><li>
Experience within medical device, digital health, pharmacy services, or healthcare technology sectors.</li><li>
Experience interacting with regulatory authorities, boards of directors, and executive leadership teams.</li><li>
Experience supporting public company governance or companies preparing for public listing preferred.</li></ul><p>
Knowledge:</p><ul><li>
FDA medical device regulations and Quality System Regulation (21 CFR Part 820)</li><li>
Health Canada medical device regulatory frameworks</li><li>
ISO 13485 quality management systems</li><li>
HIPAA and healthcare privacy regulations</li><li>
Stark Law and Anti-Kickback Statute</li><li>
Healthcare fraud and abuse laws</li></ul><p>
Skills:</p><ul><li>
Strong executive leadership and regulatory strategy capabilities</li><li>
Deep expertise in compliance risk management and regulatory governance</li><li>
Ability to engage effectively with regulators, executive leadership, and boards of directors</li><li>
Excellent communication and organizational leadership skills</li></ul></div>

Chief Compliance & Regulatory Officer (CCRO)

Gentiva

<div>Overview:
<div>
The <b>Director of Clinical Survey </b>will directly report to the Associate Vice President of Clinical Operations and Survey. This position will assist branches in meeting all applicable regulatory and company requirements in preparation for internal and external inspections, surveys, and reviews (including state licensure, federal certifications, and accreditation). The Director of Clinical Survey will develop, when applicable, and direct the implementation of corrective action plans in branches as a result of unfavorable internal or external survey outcomes with standard deficiencies, or if requested from operational, clinical, compliance or legal leadership.</div>
Essential Functions:
<ul><li>First responder to ACHC Accreditation Surveys and other external surveys as needed.</li><li>
Monitor agency level adherence to policies and procedures.</li><li>
Monitor compliance with patient records and other quality assurance activities.</li><li>
Coordinate with the appropriate area, regional and corporate staff, including Medical Director, Clinical Manager, Executive Director, Administrators and Area Vice Presidents of Operations on a regular basis to achieve survey success.
</li><li>Drive agency preparedness in meeting all applicable regulatory and company requirements, by ensuring the implementation of the company&rsquo;s systems, policies, and standards in preparation for internal and external surveys, and reviews, including state licensure, federal certifications, and accreditation.
</li><li>Provide expertise to branch directors and staff, as well as up-line management, regarding follow-up action for correction of deficiencies and identification of operational issues. Provide support, when indicated, for resolution of identified deficiencies in conditional surveys.</li><li>
Perform other duties as assigned.</li></ul>
About You:
<div><b>
Specialized Knowledge/Skills:</b></div><ul><li>
Familiarity with state and federal guidelines and regulations.</li><li>
Ability to work with confidential information.</li><li>
Well organized and confident to work independently and as a team player.</li><li>
Ability to communicate clearly with remote field, mid-level, and executive staff.</li><li>
Exercise professional judgement and demonstrate good problem-resolution skills.</li><li>
Very comfortable working with multiple online and computer applications.</li><li>
Ability to balance multiple tasks and manage conflicting priorities.</li><li>
Strong follow-up skills.</li><li>
Extensive travel and frequent overnight travel</li></ul><div><b>
Education/Experience:</b></div><ul><li>
RN degree required; bachelor&rsquo;s degree in nursing preferred.</li><li>
Two years previous managerial experience, of which 3 years is in Hospice/Home Health service industry, is preferred.</li><li>
Familiarity with state and federal guidelines and regulations.</li></ul><div><b>
License/Certification:</b></div><ul><li>
Valid driver&rsquo;s license and automobile liability insurance coverage</li><li>
Unencumbered and active RN license in state of residence required if RN</li></ul><div><b>
Training/Equipment:</b></div><ul><li>
Intermediate Excel skills</li><li>
Basic PowerPoint skills</li><li>
Experience reviewing data in electronic systems</li><li>
Experience with HomeCare-HomeBase preferred</li></ul>
We Offer:
<div><b>
Benefits for All Associates (Full-Time &amp; Per Diem):</b></div><ul><li>
Competitive Pay</li><li>
401(k) with Company Match</li><li>
Career Advancement Opportunities</li><li>
National &amp; Local Recognition Programs</li><li>
Teammate Assistance Fund</li></ul><div><b>
Additional Full-Time Benefits:</b></div><ul><li>
Medical, Dental, Vision Insurance</li><li>
Generous Paid Time Off + 7 Paid Holidays</li><li>
Wellness Programs (Telemedicine, Diabetes Management, Joint &amp; Spine Concierge Care)</li><li>
Education Support &amp; Tuition Assistance</li><li>
Company-paid Life &amp; Long-Term Disability Insurance</li><li>
Voluntary Benefits (Pet, Critical Illness, Accident, LTC)</li></ul>
Legalese:
<ul><li>This is a safety-sensitive position</li><li>
Employee must meet minimum requirements to be eligible for benefits</li><li>
Where applicable, employee must meet state specific requirements</li><li>
We are proud to be an EEO employer</li><li>
We maintain a drug-free workplace</li></ul>
Location: Gentiva Hospice Our Company:<p></p><div><br>
At Gentiva, it is our privilege to offer compassionate care in the comfort of wherever our patients call home. We are a national leader in hospice care, palliative care, home health care, and advanced illness management, with nearly 600 locations and thousands of dedicated clinicians across 38 states.</div><div></div><div><br>
Our place is by the side of those who need us &ndash; from helping people recover from illness, injury, or surgery in the comfort of their homes to guiding patients and their families through the physical, emotional, and spiritual effects of a serious illness or terminal diagnosis.</div><div></div><div><br>
Our nationwide reach is powered by a family of trusted brands that include:</div><ul><li><b>
Hospice care:</b> Gentiva Hospice, Emerald Coast Hospice Care, Heartland Hospice, Hospice Plus, New Century Hospice, Regency SouthernCare, SouthernCare Hospice Services, SouthernCare New Beacon</li><li><b>
Palliative care:</b> Empatia Palliative Care, Emerald Coast Palliative Care</li><li><b>
Home health care:</b> Heartland Home Health</li><li><b>
Advanced illness management:</b> Illumia Health</li></ul><div></div><div><br>
With corporate headquarters in Atlanta, Georgia, and providers delivering care across the U.S., we are proud to offer rewarding careers in a collaborative environment where inspiring achievements are recognized &ndash; and kindness is celebrated.</div></div>

Director Clinical Survey

Commercial Bank

<div>
 <strong>
  About Commercial Bank Of Qatar
  <br/>
  <br/>
 </strong>
 Commercial Bank, founded in 1975 and headquartered in Doha, plays a vital role in Qatar&rsquo;s economic development by offering a range of personal, business, government, international and investment services. We believe in empowering our employees, providing them with opportunities for growth and professional development.
 <br/>
 <br/>
 By Joining us, you&rsquo;ll be part of a workplace culture that fosters innovation, supports work-life balance, and encourages you to reach your full potential.
 <br/>
 <br/>
 Join us in shaping the future of banking!
 <br/>
 <br/>
 <strong>
  Job Summary
  <br/>
  <br/>
 </strong>
 Lead and oversee the Bank&rsquo;s Regulatory Reporting function, ensuring the accurate, timely, and high-quality preparation and submission of all regulatory reports to key authorities, including Qatar Central Bank, Credit Bureau, General Tax Authority, and other relevant regulators.
 <br/>
 <br/>
 <strong>
  Drive Excellence In Regulatory Compliance By Ensuring
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Superior data quality, accuracy, and adherence to defined thresholds
  </li>
  <li>
   Complete, comprehensive, and consistent reporting across all regulatory channels
  </li>
  <li>
   Robust validation processes, including logical integrity checks on data definitions, relevance, and interdependencies
  </li>
  <li>
   Strict adherence to regulatory timelines and submission deadlines
   <br/>
   <br/>
  </li>
 </ul>
 Provide strategic direction, technical guidance, and continuous training to the regulatory reporting team, fostering strong report development, structuring, and governance standards.
 <br/>
 <br/>
 Act as the primary liaison between internal stakeholders across the Bank and external regulatory bodies, managing reporting submissions, enhancements, testing cycles, and ongoing regulatory developments to ensure alignment and proactive compliance.
 <br/>
 <br/>
 <strong>
  Key Responsibilities
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Lead the preparation, validation, and submission of regulatory reports to Qatar Central Bank, Credit Bureau, and other authorities, ensuring full reconciliation, completeness, and strict adherence to deadlines.
  </li>
 </ul>
 <ul>
  <li>
   Maintain exceptional regulatory data quality standards by monitoring accuracy thresholds, resolving discrepancies, clearing exceptions within TAT, and ensuring consistency across all reporting channels.
  </li>
  <li>
   Design, automate, and enhance reporting processes using SQL scripting and BI tools, achieving high levels of automation and minimizing manual intervention.
  </li>
  <li>
   Develop, test, and deploy reporting and monitoring solutions, coordinating SIT/UAT cycles and obtaining stakeholder approvals prior to production release.
  </li>
  <li>
   Build and maintain Business Intelligence dashboards and analytical models to support risk management, compliance monitoring, and business decision-making.
  </li>
  <li>
   Support AML transaction monitoring and sanctions systems through rule optimization, tuning, data feed validation, and remediation of model validation findings.
  </li>
  <li>
   Analyze customer, product, and transactional data to identify trends, risk exposures, and actionable insights, supporting compliance and business initiatives.
  </li>
  <li>
   Collaborate with internal stakeholders (Risk, Compliance, Operations, Finance, and IT) to resolve production issues, address disputes, and support process improvements.
  </li>
  <li>
   Provide training, guidance, and advisory support on regulatory reporting, data governance, and reporting tools to business and operational teams.
  </li>
  <li>
   Drive continuous improvement initiatives by re-engineering reports, modernizing monitoring capabilities, and supporting compliance technology roadmap implementation.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Key Competencies
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Strong analytical and problem-solving capabilities with a practical, solution-oriented mindset for handling complex business and regulatory challenges.
  </li>
  <li>
   Excellent attention to detail and quality-driven approach, ensuring accuracy, integrity, and reliability across data and reporting processes.
  </li>
  <li>
   Solid banking knowledge, including financial statements, banking products, and familiarity with risk (ECL, NPLs) and compliance frameworks.
  </li>
  <li>
   Advanced data analysis skills with the ability to interpret large datasets and generate meaningful insights for decision-making.
  </li>
  <li>
   Effective stakeholder management skills, collaborating across departments and confidently engaging with external regulators.
  </li>
  <li>
   Strong organizational and multitasking abilities with full ownership mindset, prioritizing deliverables and consistently meeting strict deadlines with high integrity.
  </li>
  <li>
   Confident communicator and team contributor with strong English proficiency (Arabic is an advantage), supporting collaboration and team development.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications &amp; Expereinces
  <br/>
  <br/>
 </strong>
 Required Qualifications:
 <br/>
 <br/>
 <ul>
  <li>
   MBA, Master Degree or Equivalent Post Graduation in Finance.
  </li>
  <li>
   Parallel qualification in Computer Science / Technology is a major plus.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Required Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   +7 Years of experience in finance / risk reporting.
  </li>
  <li>
   Worked in Banking Finance and/or Banking risk areas.
  </li>
  <li>
   Software Exposure: Databases and corresponding SQLs (IBM Cognos Analytics, Microsoft Power BI , SSRS,SSIS,SSAS , SunGard Focus, IBM Infosphere is a major plus)
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Why Commercial Bank
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Best Performing Bank in Qatar in The Banker&rsquo;s prestigious Top 1000 World Banks Rankings 2025.
  </li>
  <li>
   Best Digital Bank in the Middle East 2024 by World Finance and Best Mobile Banking App in the Middle East 2024 by Global Finance.
  </li>
  <li>
   An Innovation-Driven, Digital-First Environment where employees work with the latest tools and technologies to redefine banking
  </li>
  <li>
   Opportunities for Global Partnerships &amp; International Exposure, connecting employees with global networks and perspectives.
  </li>
  <li>
   A focus on Employee Well-being &amp; Work-Life Balance, ensuring a healthy and supportive environment for all team members
  </li>
  <li>
   Competitive Compensation &amp; Benefits that ensure our employees are rewarded for their dedication and performance
  </li>
  <li>
   A strong Commitment to Diversity, Equity &amp; Inclusion, fostering a culture that values every individual&rsquo;s unique perspective
   <br/>
   <br/>
  </li>
 </ul>
 At Commercial Bank, we don&rsquo;t just offer careers, We shape futures by pioneering
 <strong>
  digital transformation
 </strong>
 in Qatar&rsquo;s banking sector,
 <strong>
  blending digital-first
 </strong>
 approach to redefine banking through
 <strong>
  innovative solutions.
  <br/>
  <br/>
 </strong>
 <strong>
  Disclaimer
  <br/>
  <br/>
 </strong>
 We appreciate your interest in joining CBQ! Please note that only selected candidates will be contacted for further steps in the hiring process. This job posting is for informational purposes only, and CBQ reserves the right to modify, withdraw, or close it at any time without notice.
</div>


Head of Regulatory Reporting

HealthTrackRx

<div><p><b>Job Summary:</b></p><p>
The Director of Lab Regulatory and Quality leads and integrates regulatory compliance, credentialing oversight, and quality management across the organization. This role ensures adherence to all applicable federal, state, accrediting, and professional standards while fostering a culture of continuous improvement, patient safety, and operational excellence. The Director partners closely with Revenue Cycle Management on state licensure enrollment and documentation, collaborates with Clinical Affairs on technical assessments and studies required by Medicare Administrative Contractors, and oversees state positivity and CDC reporting. In addition, this role provides leadership over quality assurance, training development, document control, and regulatory reporting, ensuring ongoing readiness for audits and inspections under CAP, CLIA, and OSHA requirements. Serving as a key advisor to executive leadership, laboratory leadership, and clinical teams, the Director translates complex regulatory requirements into effective policies, systems, and operational practices.</p><p><b>
Essential Responsibilities/Duties:</b></p><p>
Regulatory Leadership</p><ul><li>
Ensure organizational compliance with applicable regulatory and accrediting bodies (e.g., CLIA, CAP, CMS, state agencies NYS, CA).</li><li>
Lead regulatory readiness activities, including inspections, surveys, audits, and follow-up actions.</li><li>
Develops and Submits Technical Assessment and associated studies required by MACs.</li><li>
State positivity and CDC reporting as required by each state.</li><li>
Interpret regulatory requirements and translate them into policies, procedures, and operational controls. Monitor regulatory changes and proactively assess organizational impact.</li><li>
Serve as primary liaison with regulatory agencies and accrediting organizations.</li></ul><p>
Credentialing Oversight</p><ul><li>
Oversee credentialing, licensure, certification, and recredentialing processes for applicable personnel.</li><li>
Ensure systems are in place to track expirations, renewals, and compliance with scope of practice requirements.</li><li>
Support competency assessment programs aligned with regulatory and accreditation standards.</li></ul><p>
Quality Management &amp; Performance Improvement</p><ul><li>
Lead the organization&rsquo;s Quality Management System (QMS).</li><li>
Oversee incident management, nonconformance reporting, CAPA, Process line audits and root cause analysis activities.</li><li>
Establish quality metrics, dashboards, and reporting structures.</li><li>
Lead or support process improvement initiatives to reduce risk, improve outcomes, and prevent recurrence of failures.</li></ul><p>
Audit, Investigation &amp; CAPA</p><ul><li>
Direct internal audits and risk assessments.</li><li>
Lead investigations of significant events, near misses, and mass failures.</li><li>
Ensure timely, effective corrective and preventive actions.</li><li>
Track NCE/CAPA effectiveness and sustainability.</li></ul><p>
Leadership, Training &amp; Culture</p><ul><li>
Provide training and guidance to leaders and staff on regulatory, credentialing, and quality expectations.</li><li>
Partner with operational leaders to embed quality and compliance into daily workflows.</li><li>
Mentor and develop quality and compliance staff; oversee training content development, delivery, effectiveness assessment, and documentation.</li></ul><p>
Reporting &amp; Governance</p><ul><li>
Prepare and present reports to executive leadership.</li><li>
Escalate risks appropriately and recommend mitigation strategies.</li><li>
Support strategic planning with data-driven quality and compliance insights.</li></ul><p><b>
Qualifications:</b></p><p>
Education &ndash;</p><ul><li>
Bachelor&rsquo;s degree in a relevant field; Healthcare Administration, Business, Life Sciences, Biological, Chemical, or Clinical Sciences field, Quality Management, Public Health, or Regulatory Affairs.</li><li>
Master&rsquo;s degree (MBA, MHA, MPH, MS in Regulatory Affairs or Quality)</li></ul><p>
Competencies/Skills &ndash;</p><ul><li>
Excellent verbal and written communication skills</li><li>
Ability to communicate effectively with various level stakeholders, including Executive Management</li><li>
Ability to multi-task and manage multiple concurrent projects at a departmental level</li></ul><p>
Experience &ndash;</p><ul><li>
Leadership experience in regulatory affairs, healthcare credentialing, quality assurance, compliance, or related functions.</li><li>
Proven record of managing cross-functional teams and leading complex organizational processes.</li><li>
Experience with audits, surveys, and regulatory inspections at state/federal levels</li></ul></div>

Director of Lab Regulatory & Quality

Novo Nordisk, Inc.

<div><div><div><div><div><p>Affiliate Medical Affairs Director
</p></div></div></div></div><div><div><div><div><b>Category: </b>Medical Affairs
</div></div></div></div><div><div><div><div><b>Location:
</b>Riyadh, Riyadh, SA<br>
</div></div></div></div><div></div><div><div><div><div><div>Novo Nordisk is seeking an experienced Affiliate Medical Affairs Director to lead and grow our medical affairs activities in Saudi Arabia. In this senior leadership role, you will define and deliver scientific communication strategies, build strategic relationships with Key Opinion Leaders (KOLs), support clinical and real-world evidence generation, and oversee publication and medical education initiatives. The role requires strong leadership, cross-functional collaboration, and a commitment to patient-centric scientific excellence as well as a solid understanding of the Saudi Arabia healthcare landscape.</div><br>
<div></div>
<div><b>
Key responsibilities</b></div>
<ul>
<li>Develop and execute the affiliate&rsquo;s medical affairs strategy aligned with global objectives and local healthcare priorities</li>
<li>Build, maintain and leverage relationships with KOLs, Healthcare Professionals (HCPs) and International Professional Associations (IPAs); lead advisory boards and integrate patient perspectives</li>
<li>Provide scientific input into clinical trial design and Real-World Evidence (RWE) plans; support Scientific Recruitment &amp; Retention (SRR) activities</li>
<li>Lead publication strategy and ensure timely dissemination of RWE and clinical data</li>
<li>Design and deliver medical education programs (symposia, training, virtual and face-to-face scientific meetings)</li>
<li>Ensure compliance with medical, regulatory and ethical standards; provide medical training and guidance across affiliate functions</li>
<li>Lead the medical affairs and science team across diabetes, metabolic affairs, rare diseases and NSCD &mdash; including coaching, mentoring and performance management.</li>
<li>Manage departmental budgets and ensure alignment with business priorities</li>
<li>Drive innovation in scientific communication, RWE analytics, and patient-centric engagement models</li>
<li>Leading and developing a team of five, including both people managers and individual contributors.</li></ul><br>
<div></div>
<div><b>
Qualifications
</b></div><ul><li>Advanced degree in Medicine &ndash; specialization in endocrinology is an advantage</li>
<li>At least 10 years&rsquo; experience in Medical Affairs or related roles in pharma/biotech</li>
<li>Proven expertise in scientific communication, KOL engagement and publication strategy</li>
<li>Demonstrated leadership managing cross-functional scientific teams</li>
<li>Strong understanding of clinical trial methodology (phase I&ndash;IV), RWE, regulatory and global medical affairs environments</li>
<li>Experience with budget management and people development processes (e.g., goal setting, performance reviews, IDPs)</li>
<li>Excellent communication, stakeholder management and strategic planning skills</li>
<li>Solid experience with and understanding of the marked in Saudi Arabia</li></ul><br>
<div></div>
<div><b>
About the department:</b></div>
<div>
At Novo Nordisk Saudi Arabia, the medical unit is responsible for shaping and implementing both short- and long-term medical affairs strategies across our portfolio, including scientific communication, evidence generation, and proactive external medical engagement with healthcare professionals and key opinion leaders. As a management team member, you will lead a high-performing, multidisciplinary medical affairs team dedicated to excellence in quality, safety, and compliance. This leadership role offers a unique opportunity to drive strategic priorities during a pivotal period of growth, influence cross-functional decision-making, and advance initiatives that deliver meaningful improvements in patient care.</div><br>
<div></div>
<div><b>
What we offer</b></div>
<ul>
<li>A senior leadership role with broad influence on patient-centred medical strategy in Saudi Arabia</li>
<li>Opportunity to work across therapeutic areas including diabetes, metabolic and rare diseases</li>
<li>A collaborative, global matrix environment with strong opportunities for professional growth and impact</li>
<li>A key role with the affiliate leadership team in Saudi Arabia</li></ul><br>
<div></div>
<div><b>
Deadline</b></div>
<div>
3. April 2026</div><br>
<div></div>
<div>
At Novo Nordisk, we're not chasing quick fixes &ndash; we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger &ndash; a legacy of impact that reaches far beyond today.</div></div></div></div></div></div>

Affiliate Medical Affairs Director

Search 10000+ Regulatory affairs director jobs near you this March. New roles added regularly across leading industries. Apply today.