regulatory specialist

PakLab

Job OverviewThe Quality Specialist supports the effective implementation, maintenance, and continuous improvement of PakLab&rsquo; s Quality Management System (QMS). This role is responsible for ensuring that company operations, documentation, and product-related activities consistently meet internal quality standards, customer expectations, and applicable regulatory and Good Manufacturing Practice (GMP) requirements. This position supports all quality system processes including but not limited to internal audits, deviation and nonconformance tracking, corrective and preventive actions (CAPA), change control, training documentation, external, and supplier audit. The Quality Specialist assists in monitoring compliance through routine review of quality data, participation in inspections and audits, and follow-up on all committed actions to ensure timely and effective resolution to the identified issues. The role works cross-functionally with Operations, Production, Regulatory, R&amp;D, and Supply Chain teams to help maintain compliance, support investigations, resolve quality issues, and ensure that quality considerations are appropriately integrated into operational processes. The Quality Specialist is expected to help communicate quality requirements clearly and support teams in understanding and adhering to established procedures and regulatory expectations.I. Essential Duties andResponsibilities<ul><li>Maintain and update quality system documentation, including SOPs, work instructions, and records.</li><li>Support internal audit programs by preparing schedules, conducting audits, and documenting findings.</li><li>Support external audits by preparing, staging, and follow up on committed actions.</li><li>Assist with supplier qualification, monitoring, and audits.</li><li>Review of CAPA records, deviation reports, Nonconformance records, and change controls for accuracy and compliance.</li><li>Support investigations of non-conformances, customer complaints, and product quality issues.</li><li>Assist with CAPA (Corrective and Preventive Actions) development, implementation, and verification.</li><li>Track and report quality metrics and performance trends to direct management.</li><li>Participate in training and onboarding of employees on GMP, quality procedures, and compliance requirements.</li><li>Ensure compliance with applicable GMP, FDA, ISO, and customer-specific requirements.</li><li>Support preparation for customer and regulatory audits, including FDA and ISO.</li><li>Identify opportunities for process improvements and contribute to continuous improvement initiatives.</li><li>Perform other duties as assigned.</li></ul>Required Skills and Abilities<ul><li>Strong knowledge of GMP, quality systems, and regulatory compliance requirements.</li><li>Excellent organizational, recordkeeping, and documentation control skills.</li><li>Strong analytical and problem-solving skills with attention to detail.</li><li>Effective communication and collaboration skills across departments.</li><li>Proficiency in Microsoft Office Suite and experience with quality management systems (QMS).</li><li>Ability to manage multiple priorities and deadlines in a fast-paced environment.</li><li>Experience in a high traffic Contract manufacturer preferred.</li></ul>Education and Experience Requirements<ul><li>Bachelor&rsquo;s degree in Quality, Life Sciences, Engineering, or related field preferred.</li><li>3&ndash;5 years of hands-on quality assurance and quality systems experience in a manufacturing environment.</li><li>Experience in cosmetics, pharmaceuticals, or consumer packaged goods preferred.</li><li>Experience supporting audits and compliance programs required.</li></ul>Working Conditions and Physical Demands<ul><li>Work performed in both office and manufacturing environments.</li><li>Exposure to noise, machinery, chemicals, and production materials when on the production floor.</li><li>Flexibility to work extended hours, weekends, or shifts to meet business needs and audit schedules.</li><li>Prolonged periods of sitting at a desk and working on a computer.</li><li>Frequent walking and standing on the production floor.</li><li>Ability to lift up to 25 pounds occasionally.</li></ul>Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice.Equal Employment Opportunity (EEO) StatementUniversal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.Pay: $57,600.00 - $66,000.00 per yearBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Health savings account</li><li>Paid time off</li><li>Vision insurance</li></ul>Work Location: In person

Quality and Regulatory Specialist

10X Health System

<div>ABOUT 10X HEALTH SYSTEM 
10X Health System is a pioneering company at the forefront of the health and wellness industry, dedicated to revolutionizing the way individuals approach their personal health and well-being. With a philosophy rooted in the principle that optimal health is the foundation for a life lived to the fullest, 10X Health provides cutting-edge solutions and personalized health plans designed to empower individuals to achieve and maintain peak physical and mental performance.
The company's comprehensive approach to health combines the latest advances in medical science, nutrition, fitness, and technology to offer a suite of services that include state-of-the-art diagnostic testing, individualized treatment protocols, and ongoing support from a team of world-class health professionals. 10X Health's commitment to innovation and results has established it as a leader in the health optimization space, catering to those who strive to push the boundaries of what is possible in their health journey. 
 
POSITION SUMMARY 
We are seeking a detail-oriented Regulatory Specialist to support product and marketing claims compliance across dietary supplements, wellness products, and related offerings. This role is responsible for executing structured claims review processes, maintaining substantiation documentation, and ensuring alignment with FDA, FTC, and applicable state-level advertising and labeling requirements. 
 
This position plays a critical role in supporting the regulatory function by managing high-volume, day-to-day claims review activities, enabling the broader regulatory and legal teams to focus on strategic initiatives, risk management, and regulatory expansion. The ideal candidate is process-driven, highly organized, and able to operate efficiently within established compliance frameworks while escalating higher-risk issues appropriately. 
 
OBJECTIVES 
Claims Review &amp; Substantiation Support<ul><li>
Review product, website, and marketing claims against internal guidelines and substantiation standards</li><li>
Verify alignment of claims with approved language, supporting evidence, and regulatory requirements</li><li>
Identify and flag high-risk or non-compliant claims for escalation to senior regulatory or legal leadership</li><li>
Assist in maintaining consistency across product claims, marketing assets, and supporting documentation</li></ul>
Regulatory Documentation &amp; File Management<ul><li>
Organize and maintain claims substantiation files, including scientific references, summaries, and internal approvals</li><li>
Maintain documentation related to product specifications, certificates of analysis, and formulation details as they relate to claims support</li><li>
Ensure documentation is audit-ready and aligned with internal quality and compliance expectations</li><li>
Support internal audits, documentation reviews, and regulatory readiness initiatives</li></ul>
Cross-Functional Support &amp; Communication<ul><li>
Serve as a point of contact for marketing and cross-functional teams on claims-related questions</li><li>
Provide approved language and ensure consistency in claim usage across channels</li><li>
Respond to internal requests in a timely manner while adhering to established review processes</li><li>
Coordinate with regulatory, legal, and product teams to ensure alignment on claims-related decisions</li></ul>
Tracking, Reporting &amp; Process Adherence<ul><li>
Track key metrics including volume of claims reviewed, turnaround time, and escalation rates</li><li>
Maintain logs of reviewed assets and associated determinations</li><li>
Support continuous improvement of claims review workflows and documentation practices</li><li>
Adhere strictly to established SOPs, templates, and regulatory review processes</li></ul>
COMPETENCIES<ul><li>
Strong attention to detail and ability to review content against defined standards</li><li>
Ability to follow structured processes and maintain consistency across high-volume reviews</li><li>
Foundational understanding (or ability to learn) of FDA/FTC requirements for dietary supplements and advertising</li><li>
Ability to identify potential regulatory risk and escalate appropriately</li><li>
Strong organizational and documentation management skills</li><li>
Effective written and verbal communication skills</li><li>
Comfortable working in a fast-paced, high-growth environment with evolving priorities</li></ul>
EDUCATION &amp; EXPERIENCE<ul><li>
Bachelor&rsquo;s degree or equivalent work experience</li><li>
1&ndash;3 years of experience in regulatory, quality, compliance, or related operational roles strongly preferred</li><li>
Experience in dietary supplements, food, cosmetics, or health/wellness industries is a plus</li><li>
Exposure to claims review, labeling, or marketing compliance processes preferred</li><li>
Experience working with document management systems or asset review platforms is a plus</li></ul>
PHYSICAL REQUIREMENTS<ul><li>
Prolonged periods of sitting at a desk</li><li>
Must be able to lift up to 15 pounds at times</li></ul>
COMMITMENT TO DIVERSITY 
As an equal opportunity employer committed to meeting the needs of a multigenerational and multicultural workforce, 10X Health System recognizes that a diverse staff, reflective of our community, is an integral and welcome part of a successful and ethical business. We hire local talent at all levels regardless of race, color, religion, age, national origin, gender, gender identity, sexual orientation, or disability, and actively foster inclusion in all forms both within our company and across interactions with clients, candidates, and partners. If you require any accommodations during the application process or have any questions, please contact careers@10xhealthsystem.com. 
 
NO SOLICITATION POLICY 
10X Health does not accept unsolicited resumes, calls, or communications from staffing agencies or third-party recruiters. Any such submissions will be considered the sole property of 10X Health and will not obligate the company to pay any fees. Please refrain from contacting us regarding this posting. 
#LI-CM1 #LI-Onsite
63FDL9JCvO</div>

Regulatory Specialist, Claims Review

Job Summary The Quality &amp; Regulatory Senior Specialist plays a critical role in supporting PakLab&rsquo;s Quality and Regulatory organization through the oversight, maintenance, and continuous improvement of the PakLab Quality Management System (QMS). This role ensures that company operations, products, and documentation consistently meet internal quality standards, customer expectations, and all applicable regulatory requirements.The position is responsible for managing and supporting key quality and regulatory processes including, but not limited to, training program administration, internal and external audits, customer complaint investigations, validation and qualification activities, change control, deviation and CAPA management, regulatory documentation requests, label and artwork review, regulatory licensing and registrations, and formal regulatory correspondence.The Sr. Specialist is expected to ensure that all quality records are complete, accurate, inspection-ready, and maintained in accordance with Good Manufacturing Practices (GMP) and company procedures. In this role, the individual will act as a subject matter expert for quality and regulatory compliance, providing guidance to cross-functional teams and helping ensure that business decisions appropriately consider regulatory and quality risk. The Sr. Specialist will work closely with Operations, Production, Regulatory Affairs, R&amp;D, Supply Chain, and Commercial teams to proactively identify compliance risks, resolve quality issues, support product lifecycle activities, and implement effective corrective and preventive actions when required.The position requires a hands-on, detail-oriented professional who can operate both tactically and strategically within the organization. Beyond routine QMS management, the Sr. Specialist is expected to actively contribute to process improvement initiatives, quality culture development, and operational excellence efforts. This includes supporting the development and monitoring of Key Performance Indicators (KPIs), trending quality data, identifying systemic issues, and recommending improvements to strengthen the overall effectiveness of the Quality Management System.The Quality &amp; Regulatory Sr. Specialist is also expected to maintain a high level of inspection readiness, supporting regulatory inspections, customer audits, and internal assessments. The role requires strong organizational, analytical, and communication skills, as well as the ability to clearly articulate regulatory expectations and quality requirements to stakeholders across the organization.Ultimately, this position plays an important role in ensuring that PakLab maintains a robust, compliant, and continuously improving quality system, while supporting the organization&rsquo;s commitment to product safety, regulatory compliance, and customer satisfaction.Essential Duties and Responsibilities<ul><li>Maintain and manage overall QMS processes and documentation.</li><li>Manage the internal audit program by preparing schedules, conducting audits, and documenting findings.</li><li>Manage and host the external audit program including preparation, staging, hosting, and corresponding.</li><li>Support and oversee supplier qualification, monitoring, and audits.</li><li>Review customer complaint reports, audit response reports, and change control reports for accuracy and compliance.</li><li>Manage and support investigations of non-conformances, customer complaints, and product quality issues.</li><li>Manage and support CAPA (Corrective and Preventive Actions) development, implementation, and verification.</li><li>Track and report quality metrics and performance trends to management.</li><li>Participate in training and onboarding of employees on GMP, quality procedures, and compliance requirements.</li><li>Manage and oversee document control system and training compliance.</li><li>Ensure compliance with applicable GMP, FDA, ISO for drugs and cosmetics as well as customer-specific requirements.</li><li>Oversee and support preparation for customer and regulatory audits, including FDA and ISO.</li><li>Identify opportunities for process improvements and contribute to continuous improvement initiatives.</li><li>Perform other duties as assigned.</li></ul>Required Skills and Abilities<ul><li>Strong knowledge of FDA drug and cosmetic requirements, ISO 22716, CGMP, quality systems, and regulatory compliance requirements.</li><li>Excellent organizational, recordkeeping, and documentation control skills.</li><li>Strong analytical and problem-solving skills with attention to detail.</li><li>Effective communication and collaboration skills across departments.</li><li>Proficiency in Microsoft Office Suite and hands on experience with quality management systems (QMS).</li><li>Ability to manage multiple priorities and deadlines in a fast-paced environment.</li><li>Self-starter, out of box thinker, and a change agent advocate .</li></ul>Education and Experience Requirements<ul><li>Bachelor&rsquo;s degree in Quality, Life Sciences, Engineering, or related field preferred.</li><li>5-7 years of hands on regulatory compliance , quality assurance, and quality systems experience in a high volume manufacturing environment.</li><li>Experience in cosmetics, pharmaceuticals, or consumer packaged goods required.</li><li>Experience supporting audits and compliance programs required.</li></ul>Physical Demands and Working Conditions<ul><li>Prolonged periods of sitting at a desk and working on a computer.</li><li>Frequent walking and standing on the production floor.</li><li>Ability to lift up to 25 pounds occasionally.</li><li>Onsite working hours in core business hours.</li><li>Work performed in both office and manufacturing environments.</li><li>Exposure to noise, machinery, chemicals, and production materials when on the production floor.</li><li>Flexibility to work extended hours, weekends, or shifts to meet business needs and audit schedules.</li></ul>Other DutiesPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice.Equal Employment Opportunity (EEO) StatementUniversal Packaging Systems, Inc. DBA PakLab is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity, gender expression, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other characteristic protected by applicable federal, state, or local law.Pay: $95,000.00 - $110,000.00 per yearBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Health insurance</li><li>Health savings account</li><li>Vision insurance</li></ul>Work Location: In person

Senior Quality and Regulatory Specialist

Vodafone

<div><div><div><div><h2 class="jobSectionHeader">Join Us</h2>
</div><div>
At Vodafone, we&rsquo;re not just shaping the future of connectivity for our customers &ndash; we&rsquo;re shaping the future for everyone who joins our team. When you work with us, you&rsquo;re part of a global mission to connect people, solve complex challenges, and create a sustainable and more inclusive world. If you want to grow your career whilst finding the perfect balance between work and life, Vodafone offers the opportunities to help you belong and make a real impact.</div></div><div><div><h2 class="jobSectionHeader">
Role Purpose</h2>
</div><div>
The Commercial Regulatory Senior Specialist ensures compliance with regulatory requirements and facilitates effective communication with key regulatory bodies, including the National Telecommunications Regulatory Authority (NTRA), Central Bank of Egypt (CBE), and other relevant stakeholders. This role involves analyzing regulations, advising on their impact, and coordinating with internal teams to ensure adherence to legal and commercial frameworks.</div></div><div><div><h2 class="jobSectionHeader">
Key Accountabilities &amp; Decision Ownership</h2></div><div> 
Regulatory Compliance &amp; Monitoring 
<ul><li>
Ensure compliance with NTRA, CBE, and other regulatory bodies&rsquo; policies, laws, and guidelines.</li><li>
Monitor updates in regulatory frameworks and communicate implications to relevant departments.</li><li>
Develop processes to meet regulatory requirements and reduce compliance risks.</li></ul> 
Stakeholder Engagement 
<ul><li>
Act as the primary liaison with NTRA, CBE, and other key regulatory stakeholders.</li><li>
Build and maintain strong relationships with regulatory authorities to facilitate smooth communication.</li><li>
Respond promptly to regulatory inquiries and coordinate submissions of required documentation.</li></ul> 
Policy Analysis &amp; Advice 
<ul><li>
Analyze regulations, policies, and market developments to assess their impact on the business.</li><li>
Advise management on compliance strategies and regulatory risks.</li><li>
Contribute to the development of internal policies to align with regulatory changes.</li></ul> 
Reporting &amp; Documentation 
<ul><li>
Prepare reports and regulatory submissions, ensuring accuracy and timeliness.</li><li>
Maintain records of all regulatory interactions and documentation for audit and reporting purposes.</li></ul> 
Cross-Functional Collaboration 
<ul><li>
Work closely with legal, compliance, and commercial teams to address regulatory challenges.</li><li>
Provide training and guidance to internal teams on regulatory requirements.</li></ul> 
Market Research &amp; Insights 
<ul><li>
Conduct research on regulatory trends in the telecommunications and financial sectors.</li><li>
Identify opportunities or challenges posed by emerging regulations.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Core Competencies, Knowledge, and Experience</h2></div><div> 
<ul><li>
In-depth knowledge of NTRA and CBE regulations, as well as other relevant regulatory bodies.</li><li>
Strong analytical and problem-solving skills.</li><li>
Excellent written and verbal communication skills in English and Arabic.</li><li>
Ability to manage multiple stakeholders and balance competing priorities.</li><li>
Detail-oriented with a proactive approach to risk identification and mitigation.</li><li>
Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).</li></ul> 
Must have technical / professional qualifications: 
<ul><li>
Bachelor&rsquo;s degree in Law, Business Administration, or a related field.</li><li>
2+ years of experience in regulatory compliance, preferably in telecommunications or finance sectors.</li><li>
Proven experience dealing with regulatory authorities, including NTRA and CBE.</li><li>
Knowledge of commercial agreements, risk management, and reporting practices.</li></ul></div></div><div><div><h2 class="jobSectionHeader"> 
Who we are</h2>
</div><div>
We are a leading international Telco, serving millions of customers. At Vodafone, we believe that connectivity is a force for good. If we use it for the things that really matter, it can improve people's lives and the world around us. Through our technology we empower people, connecting everyone regardless of who they are or where they live and we protect the planet, whilst helping our customers do the same.
Belonging at Vodafone isn't a concept; it's lived, breathed, and cultivated through everything we do. You'll be part of a global and diverse community, with many different minds, abilities, backgrounds and cultures. ;We're committed to increase diversity, ensure equal representation, and make Vodafone a place everyone feels safe, valued and included.
If you require any reasonable adjustments or have an accessibility request as part of your recruitment journey, for example, extended time or breaks in between online assessments, please refer to https://careers.vodafone.com/application-adjustments/ for guidance.
Together we can.</div></div></div></div>

FS Regulatory Sr. Specialist

Parkville

<div>
 
 
 &ldquo;Parkville is committed to diversity, equity, and inclusion, and all employees are expected to support these values in all aspects of their work.&rdquo;
 
 
 
 
 
 
 
 
 Responsibilities:
 
 
 
 
 
 
 <ul>
 <li>
 Coordinate the preparation and submission of regulatory documents for Parkville&rsquo;s products, ensuring compliance with relevant standards.
 </li>
 <li>
 Stay updated on changes to economic, registration, and submission guidelines, maintaining regulatory documentation databases accordingly.
 </li>
 <li>
 Conduct weekly visits to the Ministry of Health to track pipeline status and address any required modifications during the registration and variation phases.
 </li>
 <li>
 Review product specifications, labeling, and batch records for compliance with applicable regulations and prepare necessary importation approvals for active pharmaceutical ingredients (APIs).
 </li>
 <li>
 Respond to governmental agencies' requests for product data and regulatory affairs statements, ensuring timely communication.
 </li>
 <li>
 Compile and organize re-registration files in accordance with ministerial decrees, ensuring all documentation is complete and accessible.
 </li>
 <li>
 Develop and review product leaflets (SPC &amp; PIL) and submit them to the appropriate regulatory authorities for approval.
 </li>
 <li>
 Prepare and maintain required stability files, bioequivalence files, and analytical dossiers for submission to regulatory bodies. of Health / CAPA.
 </li>
 </ul>
 
 
 
 
 
 
 Requirements:
 
 
 
 
 
 Education:
 
 
 
 Bachelor&rsquo;s degree from reputable university Degree in Pharmacy, Veterinary Medicine, Science is an advantage.
 
 
 
 
 
 
 Experience:
 
 
 
 Previous experience in pharmaceuticals industry from 3-4 years in the same position, responsibilities.
 
 
 
</div>

Regulatory Affairs Specialist

University Hospitals

<div><div>Description
What You Will Do 
<ul><li>
Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigator(s) at University Hospitals Case Medical Center. (20%)</li><li>
Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal/external agencies or committees. (20%)</li><li>
Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials. (30%)</li><li>
Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations. (20%)</li><li>
Embraces the principles and practice of leadership and professionalism in clinical research.</li><li>
Provides mentorship and training on the clinical trial and regulatory process to staff members. (10%)</li></ul>
Additional Responsibilities 
<ul><li>
Performs other duties as assigned.</li><li>
Complies with all policies and standards.</li><li>
For specific duties and responsibilities, refer to documentation provided by the department during orientation.</li><li>
Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.</li></ul></div><div>
Qualifications
Education 
<ul><li>
Bachelor's Degree and some related experience (Required) or
</li><li>Associate's Degree with 4 years of clinical and/or research experience (Required)
</li></ul>Work Experience 
<ul><li>
2+ years of clinical research experience. (Required)
</li></ul>Knowledge, Skills, &amp; Abilities 
<ul><li>
Ability to prioritize the work of multiple projects. (Required proficiency)
</li><li>Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
</li><li>Ability to work consistently and effectively as part of a high performance work team. (Required proficiency)
</li><li>Ability to understand and communicate regulatory requirements to others. (Required proficiency)
</li><li>Demonstrate problem solving skills and effective negotiation skills. (Required proficiency)
</li><li>Medical terminology. (Required proficiency)
</li><li>Strong written communication skills to write and edit documents with the ability to take scientific documentation and present to the general population. (Required proficiency)
</li><li>Excellent interpersonal and verbal communication skills. (Required proficiency)
</li><li>Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments (ie Excel, Access, Word, database applications). (Required proficiency)
</li></ul>Licenses and Certifications 
<ul><li>
Society of Clinical Research Associates (SoCRA) (Required) and
</li><li>ACRP Certified Professional (ACRP-CP) (Required)
</li><li>RAPS (Required)
</li></ul>Physical Demands 
<ul><li>
Standing Occasionally
</li><li>Walking Occasionally
</li><li>Sitting Constantly
</li><li>Lifting Rarely up to 20 lbs
</li><li>Carrying Rarely up to 20 lbs
</li><li>Pushing Rarely up to 20 lbs
</li><li>Pulling Rarely up to 20 lbs
</li><li>Climbing Rarely up to 20 lbs
</li><li>Balancing Rarely
</li><li>Stooping Rarely
</li><li>Kneeling Rarely
</li><li>Crouching Rarely
</li><li>Crawling Rarely
</li><li>Reaching Rarely
</li><li>Handling Occasionally
</li><li>Grasping Occasionally
</li><li>Feeling Rarely
</li><li>Talking Constantly
</li><li>Hearing Constantly
</li><li>Repetitive Motions Frequently
</li><li>Eye/Hand/Foot Coordination Frequently
</li></ul>Travel Requirements 
<ul><li>
10%</li></ul></div></div>

Clinical Research Regulatory Specialist II, Peds Hematology/Onc (Hybrid)

Artivion

<div>Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons&rsquo; most difficult challenges in treating patients with aortic diseases. Artivion&rsquo;s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

The Regulatory Affairs (RA) Specialist is responsible for supporting day-to-day manufacturing, preparing U.S. and international submission content, and obtaining and maintaining approval for products to markets worldwide based on direction from RA management. Additionally, the RA Specialist is responsible for assessment of regulated product changes for regulatory implications and for performing regulatory activities in support of implementation. The RA Specialist will work independently and manage their own regulatory projects.

Responsibilities:
<ul>
<li>Support manufacturing site needs to meet local objectives and maintain regulatory compliance.</li>
<li>Provides support for product regulatory compliance maintenance activities for approved products.</li>
<li>Responsible to maintain compliance for marketed products, including review of labeling, promotional material, product change assessments and documentation for changes.</li>
<li>Support regulatory commercialization activities, including listing and authorization within the enterprise resource system and/or other related databases.</li>
<li>Support regulatory compliance activities, including facility site registrations, audits, etc., as needed. Work with cross-functional teams and subject matter experts to maintain regulatory compliance.</li>
<li>Team with international regulatory colleagues to provide regulatory support for changes to existing products. Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address inquiries from international regulatory agencies.</li>
<li>Align with RA leadership on the reviews needed for significant product submissions with project stakeholders. Author accurate and complete submission content with support from management. May support leadership with addressing submission questions from external agencies.</li>
<li>Provide feedback and on-going support to product teams for regulatory questions.</li>
<li>Generates and executes regulatory or compliance activities under management direction. Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)</li>
<li>May support new product development activities in cooperation with senior RA colleagues.</li>
<li>Understand the regulatory strategy for products and execute the defined submission related activities (which may include international registrations, including renewals, annual reports and responses to requests for additional information) for product maintenance for existing approved products.</li>
<li>Maintain awareness/have a beginner to intermediate understanding of worldwide regulatory requirements; maintain awareness of agency relationship and ensure RA leadership is prepared with sufficient information to support relationships with external agency personnel.</li>
<li>Provide basic project management techniques for task management and deliver to defined plans.</li>
<li>Ensure understanding of all quality policy/system items that are applicable.</li>
<li>Follow all work/quality procedures to ensure quality system compliance and high-quality work.</li>
<li>Maintain and update regulatory processes and SOPs as directed. Provide input on improvements to processes to RA leadership and support implementation as requested.</li>
<li>Comply with all work/quality procedures to ensure quality system compliance, training requirement fulfillment, and high-quality work.</li>
<li>Uphold ethical behavior consistent with the Artivion, Inc. mission, vision and quality policy.</li>
</ul>
Qualifications:
<ul>
<li>Bachelor's degree and a minimum of 2 years of regulatory experience or an advanced degree with a minimum of 1 years of regulatory experience.</li>
<li>Experience with medium to high risk, FDA Class II or III devices or experience with EU Class IIb or III devices. May include 510(k), IDE, PMA, EU/CE Technical Documentation Files, or Canadian License.</li>
<li>Experience working with cross-functional teams.</li>
<li>Ability to comprehend principles of engineering, physiology, and medical device use.</li>
<li>Ability to effectively manage and prioritize numerous projects and responsibilities.</li>
<li>Strong analytical, technical writing, verbal/written communication, organizational, and time management skills.</li>
<li>Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.</li>
</ul>
Preferred:
<ul>
<li>Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue.</li>
<li>International work experience.</li></ul></div>

Regulatory Affairs Specialist (Hybrid - Kennesaw, GA)

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