Head of Quality Assurance & Regulatory Affairs
Barrington James
Paris
Job Title: Head of Quality Assurance & Regulatory Affairs (QA/RA)
Location: Greater Paris Area, France
Industry: Medical Devices
Company Overview:
We are a fast-growing, innovative medical device company based in the Greater Paris area, focused on developing cutting-edge solutions to improve patient care and enhance clinical outcomes. Our commitment to quality and regulatory compliance is at the core of everything we do. We are seeking an experienced and dynamic Head of QA/RA to lead our Quality Assurance and Regulatory Affairs teams and ensure our products meet the highest standards of quality and compliance globally.
Position Overview:
As the Head of Quality Assurance & Regulatory Affairs , you will be responsible for overseeing all aspects of quality and regulatory compliance, ensuring that our medical devices meet both European and international standards. You will lead a team of professionals and work closely with cross-functional departments, including R&D, production, and clinical teams, to drive the development and launch of high-quality, safe, and compliant products.
Key Responsibilities:
- Leadership & Strategy: Lead, mentor, and develop the QA/RA team to ensure high performance and alignment with the company’s goals and regulatory requirements.
- Quality Systems Management: Oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) to ensure compliance with ISO 13485, GMP, and other relevant standards.
- Regulatory Affairs: Ensure regulatory submissions and approvals for products in all target markets (EU, US, and other international markets). Maintain up-to-date knowledge of MDR (EU Medical Device Regulation) and FDA regulations and guidance.
- Compliance & Audits: Manage internal and external audits, ensuring compliance with regulatory standards, and lead corrective and preventive action (CAPA) processes.
- Product Development & Launch: Collaborate with R&D and product development teams to ensure that products are designed, tested, and manufactured according to regulatory and quality standards, including ensuring timely submissions for regulatory approvals.
- Risk Management: Oversee risk management activities for all products and processes, including risk assessments, FMEA, and post-market surveillance.
- Training & Documentation: Ensure all employees are trained on quality and regulatory requirements. Maintain comprehensive documentation for regulatory submissions, audits, and inspections.
- Continuous Improvement: Foster a culture of quality within the organization, driving continuous improvement initiatives across all operations and product lines.
Qualifications & Experience:
- Experience: Minimum of 8-10 years of experience in Quality Assurance and Regulatory Affairs within the medical device industry, with at least 3-5 years in a leadership position.
- Education: Degree in Life Sciences , Engineering , Biomedical Sciences , or a related field. Additional certifications in quality management or regulatory affairs (e.g., CQE , RAC ) are a plus.
- Expertise: In-depth knowledge of ISO 13485 , MDR (Medical Device Regulation), FDA regulations, and other global regulatory requirements for medical devices.
- Skills: Strong leadership, team management, and strategic planning abilities. Excellent communication and interpersonal skills with the ability to collaborate cross-functionally.
- Languages: Fluency in French and English (written and spoken).
Desirable Skills:
- Experience working with Class II and Class III medical devices .
- Familiarity with international regulatory frameworks (e.g., FDA , Health Canada , TGA ).
- Proven experience managing regulatory submissions, including CE marking , FDA approvals , and other global market access processes.
- Ability to adapt to a fast-paced, innovative environment while maintaining a strong focus on quality and compliance.
What We Offer:
- Competitive salary and benefits package.
- A dynamic and supportive work environment in a growing and innovative medical device company.
- Opportunities for career development and progression.
- The chance to make a direct impact on the development of life-changing products.