regulatory compliance specialist

Stellar Hunters

<div><h4 class="jobSectionHeader"><b>Job Summary</b></h4><p>
We are seeking a detail-oriented and knowledgeable <b>Regulatory Affairs Specialist</b> to ensure that products, processes, and operations comply with applicable regulatory requirements. The successful candidate will support product registrations, maintain regulatory documentation, and liaise with regulatory authorities to ensure timely approvals and ongoing compliance.</p><p>
This role requires strong understanding of regulatory frameworks, documentation accuracy، and the ability to work cross-functionally in a fast-paced, compliance-driven environment.</p><h4 class="jobSectionHeader"><b>
Key Responsibilities</b></h4><h5 class="jobSectionHeader"><b>
Regulatory Submissions &amp; Approvals</b></h5><ul><li><p>
Prepare, review, and submit regulatory dossiers and documentation to relevant authorities (e.g., SFDA or other applicable bodies).</p></li><li><p>
Track and manage product registration timelines, renewals, and approvals.</p></li></ul><h5 class="jobSectionHeader"><b>
Compliance &amp; Documentation</b></h5><ul><li><p>
Ensure all products and processes comply with local and international regulatory requirements.</p></li><li><p>
Maintain up-to-date regulatory documentation, technical files, and records.</p></li></ul><h5 class="jobSectionHeader"><b>
Regulatory Intelligence</b></h5><ul><li><p>
Monitor changes in regulations and guidelines and assess their impact on the business.</p></li><li><p>
Communicate regulatory updates to internal stakeholders and recommend necessary actions.</p></li></ul><h5 class="jobSectionHeader"><b>
Cross-functional Collaboration</b></h5><ul><li><p>
Work closely with R&amp;D, Quality, Manufacturing, and Marketing teams to ensure compliance throughout the product lifecycle.</p></li><li><p>
Support new product development by providing regulatory guidance and requirements.</p></li></ul><h5 class="jobSectionHeader"><b>
Audit &amp; Inspection Support</b></h5><ul><li><p>
Support internal and external audits, inspections, and regulatory inquiries.</p></li><li><p>
Ensure readiness and proper documentation for compliance reviews.</p></li></ul><h5 class="jobSectionHeader"><b>
Labeling &amp; Claims Review</b></h5><ul><li><p>
Review product labeling, packaging, and marketing materials to ensure regulatory compliance.</p></li><li><p>
Ensure all product claims are supported and aligned with regulatory standards.</p></li></ul><h5 class="jobSectionHeader"><b>
Continuous Improvement</b></h5><ul><li><p>
Identify opportunities to improve regulatory processes, documentation systems, and submission workflows.</p></li></ul><h4 class="jobSectionHeader"><b>
Required Qualifications - Skills &amp; Experience</b></h4><ul><li><p>
Bachelor&rsquo;s degree in Pharmacy, Life Sciences, Chemistry, or a related field.</p></li><li><p>
2&ndash;5 years of experience in regulatory affairs, preferably within pharmaceutical, medical device, or FMCG industries.</p></li><li><p>
Strong knowledge of regulatory frameworks and submission processes.</p></li><li><p>
Experience with product registration and regulatory documentation.</p></li><li><p>
Excellent attention to detail and organizational skills.</p></li><li><p>
Strong communication and stakeholder management skills.</p></li></ul><h4 class="jobSectionHeader"><b>
Preferred Qualifications</b></h4><ul><li><p>
Experience with Saudi regulatory bodies such as <b>SFDA</b>.</p></li><li><p>
Familiarity with GCC or international regulatory requirements.</p></li><li><p>
Experience with electronic submission systems and regulatory databases.</p></li><li><p>
Certification or training in regulatory affairs is a plus.</p></li></ul><h4 class="jobSectionHeader"><b>
Work Environment &amp; Compensation</b></h4><ul><li><p>
Full-time position with an onsite model.</p></li><li><p>
Competitive salary commensurate with experience and a comprehensive benefits package, including health insurance, retirement plan options, and paid time off.</p></li><li><p>
Opportunities for professional development, training, and certification support; clear paths for career growth within IT and cross-functional teams.</p></li><li><p>
Inclusive culture that values diversity, equity, work-life balance, and employee well-being.</p></li></ul></div>

Regulatory Affairs Specialist

EVA pharma

<div>
 <p>
  Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
  <br/>
  &nbsp;
 </p>
 <p>
  <strong>
   Job Summary:
  </strong>
 </p>
 <p>
  We are seeking a passionate and talented
  <strong>
   Regulatory Affairs Specialist
  </strong>
  to join our dynamic team.
 </p>
 <p>
  The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
 </p>
 <p>
 </p>
 <p>
  <strong>
   Key Responsibilities:
   <br/>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   Regulatory Compliance - Ensure all products meet international regulations, serving as the primary regulatory contact for our international hubs
  </li>
  <li>
   Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
  </li>
  <li>
   Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
  </li>
  <li>
   Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
  </li>
  <li>
   Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
   <br/>
  </li>
 </ul>
 <p>
  <strong>
   Qualifications:
   <br/>
   <br/>
  </strong>
 </p>
 <ul>
  <li>
   Bachelor's degree in Pharmaceutical Sciences
  </li>
  <li>
   +2 years of experience in Regulatory Affairs in international Markets.
  </li>
  <li>
   Fluent in English (written &amp; verbal) - essential for global collaboration
  </li>
  <li>
   Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
  </li>
 </ul>
 <p>
 </p>
</div>


360training.com

<div><div><b>360training
</b></div><div><div>360training.com is a rapidly growing leader in online training and certification across a wide range of industries and professions. 360training.com provides customers with the regulated training they need to get and keep jobs they want. Over the years, we have continued to grow our expansive library of regulatory-approved training courses with new content suited for today&rsquo;s modern workforce. By offering these courses online, all 360training.com users experience the convenience and flexibility of earning their certifications in their own time, from anywhere in the world.</div>
<div><div><br>
At 360training.com, we promote a culture of excellence centered around our two core values: Deliver Results and Do the Right Thing. That focus fosters the success of our employees, while maintaining a team-centric environment which inspires them to do their absolute best. One thing our associates get to experience is the ability to make an impact on day one of working here.</div>
<div></div><div>360training offers a compelling compensation package that ties to performance and impact. We offer quality health insurance for employees, their dependents and parent including OPD, dental and vision coverage to meet a variety of needs. We also offer benefits of life and disability, time off, leave encashment, EOBI and gratuity. With twice a year promotion opportunity.</div>
<div></div><div><b>Work Hours: The work hours will be Central Standard Time, USA i-e 06:00 pm to 03:00 am Pakistan Standard Time.</b></div>
</div>.</div>
<div><b>Compliance Reporting Specialist</b></div>
<div>360training is seeking a <b>Compliance Reporting Specialist</b> to join our growing team in Karachi, Pakistan. The Compliance Reporting Specialist will be responsible for submitting students&rsquo; course completion credit hours to the regulators for fulfilling the compliance requirement, by strictly following the reporting schedule and SOP&rsquo;s respectively for each Industry and nation-wide. The role will also be responsible for managing case by case customer issues regarding their Licensing, Certification and Continuing Education and make sure to meet the reporting targets during renewal deadlines. The position also demands resolving escalated reporting issues according to the defined SOP&rsquo;s of the said department. The position may also require maintaining good business relationship with the point of contact at the State Department and within the Company in other Departments. The position also requires contacting Customers if required to resolve their issues related to the credit reporting. The reporting specialist will also be responsible for maintaining any related documentation, which may include payment receipts of reported courses as well as documenting the processes and any changes in the reporting and audit processes including the reporting schedule.</div>
<div></div><div><b>Responsibilities</b></div>
<ul><li>To run Power Query reports according to the schedule provided by the Manager and save the reports online for backup and audit in case required.</li>
<li>Submit students&rsquo; course information (credit hours) to Regulators and maintain records.</li>
<li>Follow strict guidelines provided by the State departments on reporting credits and make sure new rules are adopted and updated in the Reporting process manuals.</li>
<li>Conduct periodic audits of reported course completions whenever required to make sure any missing student is reported.</li>
<li>To contact Customers directly when required for reporting purpose.</li>
<li>To work with various other Departments to help resolve any reporting related issues or to enhance and upgrade reporting tools.</li>
<li>To work with any other reporting specialist for any industry whenever required.</li>
<li>To maintain records of affidavits or forms received through faxes / mail / email and issue certificates.</li>
<li>To maintain credit card transaction records and receipts for the payments made to Regulators for reporting purpose.</li>
<li>To handle any reporting issue independently and handle escalations according to the department SOPs.</li>
<li>Any other responsibility assigned by the Manager.</li>
<li>Handle escalations through JIRA and resolve issues within the provided ETA.</li>
<li>Develop understanding of advanced use of Excel and Power Query on case-by-case bases.</li>
<li>Management of reporting documents and records on daily basis.</li>
<li>Follow the Regulatory Support policy to ensure timely resolutions of escalations.</li>
<li>Document reporting processes and changes in the reporting manual and keep the process manuals up to date all the time.</li>
</ul><div><b>Qualifications</b></div>
<ul><li>Bachelor of Commerce, Business Administration or any other equivalent degree is preferred. Other areas of study providing similar skill sets and experience can also be considered.</li>
<li>Must have at least 2 years of working experience in any industry providing similar skill sets required by the job.</li>
<li>Must be able to demonstrate the required core competencies at the expected proficiency level.</li>
<li>Knowledge of Microsoft Office suite including advanced use of spreadsheets is a must.</li>
<li>The knowledge of advanced use of Adobe Acrobat is a plus.</li>
<li>Must be competent in the use of the internet and should be able to browse and research information when required.</li>
<li>Excellent verbal and written communication skills are required for using email, telephone, chat, fax and any other medium of internal or external communication.</li>
<li>Understanding of American English Accent is preferred.</li>
<li>Must be competent in the use of web-based applications.</li></ul></div><div></div>

Compliance Reporting Specialist

Maine Molecular Quality Controls, Inc

<div><b>Ensure Quality &amp; Compliance as Our Next QA/RA Specialist!</b><br>
<br>
 The Quality Assurance/Regulatory Affairs Specialist plays a key role in supporting quality assurance activities and ensuring compliance with applicable regulatory requirements. Reporting to the Manager of QA/RA, this position is responsible for maintaining policies and managing procedures that support MMQCI&rsquo;s Quality System in alignment with ISO 13485 standards.<br>
The ideal candidate brings experience working within an ISO 13485-regulated environment and is comfortable supporting and maintaining quality systems. This role offers the opportunity to quickly build expertise while working in a collaborative environment.<br>
<br>
<b>What You Will Get to Do:</b><ul><li>
Review and approve all Quality Management System documentation (i.e. batch records and QC testing) to ensure compliance with QMS certifications and investigations</li><li>
Collaborate with departments to investigate Material Review Notifications and develop Corrective and Preventive Action plans</li><li>
Independently reviews and authorizes process and equipment validations</li><li>
Performs or assists with audits, including internal, customer, and regulatory audits</li><li>
Maintains MMQCI&rsquo;s ISO 13485 certification</li><li>
Writes SOPs and trains key personnel as needed to support all departments</li><li>
May be called on to assist others and perform additional tasks as assigned</li></ul><b>
</b><br>
<b>Required Skills &amp; Experience:</b><ul><li>
Bachelor&rsquo;s degree in Life Sciences with 5+ years&rsquo; experience in a cGMP-regulated environment, including at least 2 years in Quality Assurance</li><li>
Knowledge of current GMP regulations, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is preferred</li><li>
Strong written and verbal communication skills; proficient in Microsoft Suite</li><li>
Excellent proofreading skills with strong attention to detail</li><li>
Ability to manage multiple priorities in a fast-paced, changing environment and meet challenging deadlines</li><li>
Strong work ethic, team-oriented mindset, and willingness to learn</li><li>
Ability to communicate clearly and constructively</li><li>
Must be able to lift up to 30 lbs</li></ul><br>
<b>
Why You&rsquo;ll Love Working Here</b><ul><li>
Opportunity to make a meaningful impact within a growing diagnostic company</li><li>
Collaborative, mission-driven team environment</li><li>
Competitive compensation and benefits</li></ul>
<br>
<b>Benefits We Offer</b><br>
<ul><li>Medical, dental, and vision insurance</li><li>401(k)</li><li>Profit Sharing Plan</li><li>Vacation</li><li>Holidays</li><li>Sick leave</li></ul><br>
Get to know the MMQCI team!<br>
https://www.mmqci.com/about/employeespotlight/employee-spotlight.html<br>
<br>
Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and<br>
markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases. MMQCI has developed technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products.<br>
<br>
 MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We&rsquo;re in a state-of-the-art facility, located in Saco, right next to the Eastern Trail. Come join us!<p>
</p><p>9DWJ2Spgck</p></div>

Quality Assurance Specialist

PSC Biotech® Corporation

<div>
 BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team&rsquo;s expertise to create a process design for our clients&rsquo; products that best suits their needs.
 <br/>
 <br/>
 <strong>
  The Experience
  <br/>
  <br/>
  With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
  <br/>
  <br/>
  We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
  <br/>
  <br/>
  At BioTechnique, it&rsquo;s about more than just a job&mdash;it&rsquo;s about your career and your future.
  <br/>
  <br/>
  <strong>
   Your Role
   <br/>
   <br/>
   We are hiring an experienced and adaptable Quality Assurance Specialist to join BioTechnique. The QA Specialist plays a critical role in driving successful completion of operational tasks, performing quality reviews, and providing guidance to various departments to ensure adherence to regulatory requirements and industry best practices. This role also requires experience in safety programs, including acting as a safety officer and participating in internal or OSHA-related safety audits.
   <br/>
   <br/>
   <strong>
    Requirements
    <br/>
    <br/>
   </strong>
   <strong>
    Benefits
    <br/>
    <br/>
   </strong>
   Offering a full suite of benefits, BioTechnique&acirc;&cent; is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
   <br/>
   <br/>
   <strong>
    Equal Opportunity Employment Statement
    <br/>
    <br/>
   </strong>
   <ul>
    <li>
     Provide QA support to GMP areas including:
    </li>
    <ul>
     <li>
      Critical utilities (e.g., WFI, Steam, Automation, equipment, HVAC)
     </li>
     <li>
      Warehouse operations
     </li>
     <li>
      Manufacturing processes
     </li>
     <li>
      Inspection, labeling, and packaging
     </li>
     <li>
      Batch record review and disposition
     </li>
     <li>
      New product introduction and product transfer
     </li>
     <li>
      External quality and laboratories
     </li>
     <ul>
      <li>
       Support tactical QA operations by assessing and reviewing floor activities against cGMPs for real-time observation, issue identification/resolution, and proper documentation.
      </li>
      <li>
       Ensure adherence to SOPs, change control, CAPA/deviation management, risk management, and compliance with FDA/EU regulatory standards.
      </li>
      <li>
       Provide guidance to GMP areas (Manufacturing, QC, etc.) to ensure compliance with all applicable regulations.
      </li>
      <li>
       Oversee change management system for minor and major classified change controls.
      </li>
      <li>
       Identify, classify, and report deviations; support remediation and CAPA activities.
      </li>
      <li>
       Ensure timely closure of investigations and resolution of issues before process release.
      </li>
      <li>
       Collaborate with cross-functional teams to determine root cause and implement preventative/corrective actions.
      </li>
      <li>
       Perform technical review of documentation during and post-execution of cGMP activities.
      </li>
      <li>
       Communicate with clients, vendors, and external services to resolve investigations and ensure compliance.
      </li>
      <li>
       Participate in inspection readiness activities and regulatory inspections.
      </li>
      <li>
       Support safety programs and audits.
      </li>
      <li>
       Additional duties as required.
      </li>
      <li>
       Bachelor&rsquo;s degree in sciences, engineering, or related discipline.
      </li>
      <li>
       4-5 years of experience in a Quality role within the life sciences industry.
      </li>
      <li>
       At least one year of experience managing projects and priorities within complex matrix organizations.
      </li>
      <li>
       Advanced knowledge of relevant regulations (FDA, cGMP, OSHA).
      </li>
      <li>
       Experience with safety programs and audits (internal and OSHA).
      </li>
      <li>
       Proficient in using quality management tools and software.
      </li>
      <li>
       Demonstrated ability to execute strategic and tactical objectives provided by senior leaders.
      </li>
      <li>
       Experience with regulatory inspections and interactions with regulatory agencies.
      </li>
      <li>
       Strong analytical and problem-solving skills with keen attention to detail.
      </li>
      <li>
       Excellent communication and interpersonal skills; ability to work effectively in a team-oriented environment.
      </li>
      <li>
       Independent decision-making capability and ability to understand the impact of decisions.
      </li>
      <li>
       Strong organizational and project management skills; ability to manage multiple projects and timelines.
      </li>
      <li>
       Effective leadership skills.
      </li>
      <li>
       Medical, Dental, and Vision - BioTechnique pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
      </li>
      <li>
       Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
      </li>
      <li>
       401(k) and 401(k) matching
      </li>
      <li>
       PTO, Sick Time, and Paid Holidays
      </li>
      <li>
       Education Assistance
      </li>
      <li>
       Pet Insurance
      </li>
      <li>
       Discounted rate at Anytime Fitness
      </li>
      <li>
       Financial Perks and Discounts
      </li>
     </ul>
    </ul>
   </ul>
  </strong>
 </strong>
</div>


The Hollister Group

<div>
 <p>
  <strong>
   Compliance Associate
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Overview:
  </strong>
 </p>
 <p>
  Our client, a prestigious law firm, is seeking a diligent and detail-oriented Compliance Associate to join their dedicated team. This role offers a unique opportunity to work within a collaborative environment that emphasizes work-life balance, professional growth, and community engagement. You will play a vital part in ensuring the firm remains compliant with regulatory standards, supporting critical functions that uphold the company's integrity and reputation.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Compensation:
  </strong>
 </p>
 <p>
  $80,000 - $110,000 yearly salary
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Responsibilities:
  </strong>
 </p>
 <ul>
  <li>
   Collaborate closely with the Chief Compliance Officer to manage SEC and banking reporting and compliance tasks
  </li>
  <li>
   Contribute to the SEC and bank examination processes, including follow-up actions
  </li>
  <li>
   Oversee the timely preparation and submission of federal and state regulatory filings, ensuring adherence to relevant requirements such as Form ADV, Form CRS, and Form U4/U5
  </li>
  <li>
   Maintain and update the compliance calendar to track important deadlines
  </li>
  <li>
   Support the annual custody and SOC 1 audits with accurate documentation and coordination
  </li>
  <li>
   Manage the firm's pre-clearance policies, providing guidance and responding to employee inquiries
  </li>
  <li>
   Monitor trading activities, investigate alerts, and resolve violations
  </li>
  <li>
   Keep track of and communicate updates related to restricted securities and compliance policies
  </li>
  <li>
   Maintain accurate compliance records, documentation, and databases
  </li>
  <li>
   Generate reports on key compliance activities and ensure data accuracy
  </li>
  <li>
   Stay informed on regulatory changes, communicating and implementing updates across teams
  </li>
  <li>
   Liaise with internal personnel, external service providers, and regulatory agencies as needed
  </li>
  <li>
   Assist with miscellaneous compliance and risk mitigation activities
  </li>
  <li>
   Review and recommend process improvements to strengthen adherence to laws, regulations, and policies
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Requirements:
  </strong>
 </p>
 <ul>
  <li>
   2 to 4 years of experience in compliance within legal, investment advisory, broker-dealer, banking, or fiduciary services settings
  </li>
  <li>
   Bachelor&rsquo;s degree or higher, with relevant professional experience
  </li>
  <li>
   Familiarity with the Investment Advisers Act of 1940 (preferred)
  </li>
  <li>
   Knowledge of fiduciary trust operations or investment businesses (preferred)
  </li>
  <li>
   Understanding of banking laws, including anti-money laundering and the bank secrecy act (preferred)
  </li>
  <li>
   Awareness of privacy laws and related regulations (preferred)
  </li>
  <li>
   IACCP&reg; designation is a plus
  </li>
  <li>
   Strong written and verbal communication skills with the ability to exercise tact and professionalism
  </li>
  <li>
   Advanced proficiency with Microsoft Office Suite, with adaptability to new software applications
  </li>
  <li>
   Proven capacity to take ownership of tasks and meet challenging deadlines
  </li>
  <li>
   Excellent attention to detail with effective follow-up abilities
  </li>
  <li>
   Self-motivated with strong organizational skills and the ability to work efficiently under pressure
  </li>
  <li>
   Exceptional interpersonal skills and a customer-focused mindset
  </li>
  <li>
   Analytical mindset with excellent proofreading capabilities
  </li>
  <li>
   Discretion and sound judgment in handling sensitive information
  </li>
  <li>
   High energy, enthusiasm for learning, and a professional demeanor
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Our Commitment to Inclusion &amp; Belonging
  </strong>
 </p>
 <p>
  The Hollister Group is an equal opportunity employer. We welcome and encourage applications from people who are under-represented in their respective occupation or position.
 </p>
</div>


Compliance Associate

UNC Health

<div><p><b>Description</b>
</p><p>Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.</p><p><b>
Summary</b>:</p><p><br>
The HCS Regulatory Planning &amp; CON Strategy Specialist is a key member of the Regulatory Affairs &amp; Facility Strategy team and provides high-quality writing, editing, and communication support for Certificate of Need (CON), licensure, facilities planning, and related regulatory activities. Reporting to the Director of Regulatory Affairs &amp; Facility Strategy, this role is responsible for translating complex regulatory, clinical, operational, and financial information into clear, persuasive, and well-organized written materials for both internal and external audiences.</p><p>
Working closely with the Director, Regulatory Affairs &amp; Facility Strategy team members, internal stakeholders, and external advisors, this position plays a critical role in shaping narratives, ensuring consistency and accuracy across regulatory submissions, and supporting leadership communications related to regulatory strategy and facilities planning. This position serves as a key bridge between technical analysis and effective storytelling within a highly regulated environment.</p><p></p><p><b><br>
Responsibilities</b>:<br>
<b>Regulatory &amp; CON Support:</b> Assists in the preparation, coordination, and submission of CON applications and related filings. Drafts, edits, and refines narrative components of CON applications, regulatory filings, and related submissions to ensure clarity, consistency, and alignment with regulatory requirements and organizational strategy. Assists with drafting and submitting Progress and Annual Reports, License Renewal Applications (LRAs), ad hoc filings (e.g. CON Exemptions, Material Compliance Requests, Equipment Replacement Requests). Collaborates with outside advisors during the development of CON applications and throughout comments, appeals, and litigation processes and to support written responses and filings. Ensures written materials accurately reflect approved strategy, data, and leadership direction.<br>
<b>Strategic Communications &amp; Messaging: </b>Synthesizes complex regulatory, operational, clinical, and financial information into clear and compelling written materials for leadership, committees, task forces, and workgroups. Coordinates and collaborates with marketing, communications, and PR teams on public announcements with respect to CON applications, regulatory activity, and other strategic and growth initiatives. Prepares executive summaries, briefing documents, presentations, and talking points related to regulatory strategy, facilities planning, and competitive activity. Supports development of consistent messaging across regulatory submissions, internal communications, and external-facing materials.<br>
<b>Research, Review, &amp; Content Analysis:</b> Reviews regulatory requirements, policies, and guidance to ensure written materials align with applicable rules, methodologies, and planning assumptions. Assists in preparing written comments, petitions, and summaries related to the State Medical Facilities Plan (SMFP) and other planning processes. Edits and quality-checks regulatory documents for accuracy, completeness, formatting, and compliance prior to submission.<br>
<b>Communication &amp; Collaboration:</b> Works collaboratively with internal departments (planning, finance, operations, clinical leadership, communications) to gather, clarify, and translate information into written form. Supports communication with external consultants, legal counsel, and regulatory agencies under the direction of the Director. Helps maintain organized document libraries and version control for regulatory and planning-related materials.</p><p></p><h3 class="jobSectionHeader"><b><br>
Other Information</b></h3><div>
Other information:<br>
<b>Education Requirements:</b><br>
<ul><li>Bachelor&rsquo;s degree in public health, healthcare administration, public policy, planning, English, communications, or a related field required.</li></ul><b>
Licensure/Certification Requirements:</b><br>
<ul><li>None required.</li></ul><b>
Professional Experience Requirements:</b><br>
<ul><li>Requires five (5) years of experience in healthcare, regulatory affairs, policy analysis, strategic planning, or professional writing.</li><li>Experience with regulatory, legal, or technical writing in a healthcare or government setting is strongly preferred.</li></ul><b>
Knowledge/Skills/and Abilities Requirements:</b><br>
<ul><li>Exceptional writing, editing, and proofreading skills, with the ability to communicate complex and technical information clearly and persuasively.</li><li>Strong analytical and synthesis skills; ability to integrate data, policy, and strategy into cohesive narratives.</li></ul>
High attention to detail and commitment to accuracy and consistency.<br>
<ul><li>Ability to manage multiple writing projects and deadlines simultaneously.</li><li>Strong collaboration and communication skills in a multidisciplinary environment.</li><li>Proficiency in Microsoft Word, PowerPoint, and Excel; familiarity with document management and version control best practices.</li></ul></div><h3 class="jobSectionHeader"><b><br>
Job Details</b></h3><p>
Legal Employer: NCHEALTH</p><p>
Entity: Shared Services</p><p><br>
Organization Unit: Legal Office
</p><p>Work Type: Full Time</p><p><br>
Standard Hours Per Week: 40.00</p><p>
Salary Range: $41.45 - $59.58 per hour (Hiring Range)</p><p><br>
Pay offers are determined by experience and internal equity</p><p><br>
Work Assignment Type: Onsite</p><p>
Work Schedule: Day Job</p><p>
Location of Job: US:NC:Morrisville</p><p>
Exempt From Overtime: Exempt: Yes</p><p></p><p><br>
This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Health Care System, in a department that provides shared services to operations across UNC Health Care; except that, if you are currently a UNCHCS State employee already working in a designated shared services department, you may remain a UNCHCS State employee if selected for this job.</p><p></p><p><br>
Qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, status as a protected veteran or political affiliation.<br>
<br>
UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email applicant.accommodations@unchealth.unc.edu if you need a reasonable accommodation to search and/or to apply for a career opportunity.</p></div>

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