Head of RA-QA​/PRRC

Head of RA/QA

My client is an innovative Life Sciences company in the Zurich area, developing advanced medical technologies in a highly regulated international environment under ISO 13485 standards.

• Employment Type:
  
  long term Permanent Employment
• Location:
  
  Zürich (Hybrid)
• Start Date:
  
  01.11.2026

Overview We are currently seeking a Head of QA/RA to join our client's growing team and lead the global Quality Assurance and Regulatory Affairs function, driving regulatory strategy, quality excellence, compliance, and market expansion across international medical device markets.

• Lead and develop the global QA/RA function, including team management, coaching, and strategic leadership
• Define and execute the Quality Assurance and Regulatory Affairs strategy, ensuring alignment with business objectives and growth plans for existing and new product registrations
• Act as the Person Responsible for Regulatory Compliance (PRRC) or ensure fulfillment of PRRCresponsibilities in accordance with EU MDR 2017/745
• Own the Quality Management System (QMS), regulatory compliance, audits, inspections, CAPA processes,and continuous improvement initiatives
• Ensure compliance with FDA, EU MDR, ISO standards, GMP requirements, and other applicable globalregulations
• Lead regulatory submissions, product registrations, product changes, market approvals, and lifecyclemanagement activities across Europe, USA, Asia-Pacific, and South America
• Ensure ongoing compliance for products already on the market and support international market expansion
• Lead cross-functional collaboration with R&D, Manufacturing, Quality Control (QC), Clinical, Commercial,Quality Engineering, and external partners including CMOs and CDMOs
• Act as the primary contact for regulatory authorities, notified bodies, auditors, and key external stakeholders
• Drive quality, manufacturing, and operational improvement initiatives to ensure product quality, compliance,and scalable business growth

• Advanced degree (Master's, PhD, or equivalent) in Life Sciences, Biomedical Engineering, Natural Sciences,or a related field
• 5-10 years of Medical Device experience across Regulatory Affairs, Quality Assurance, and/or Clinical Research within ISO 13485 environments
• Proven leadership experience in QA/RA, including team management, strategic planning, and stakeholder engagement
• PRRC experience or eligibility under EU MDR 2017/745
• Strong knowledge of EU MDR 2017/745, FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, ISO
  11137, GMP, and global regulatory frameworks
• Experience with regulatory submissions, registrations, product changes, lifecycle management, Technical Documentation, QMS, CAPA, and post-market compliance
• Experience managing FDA audits, notified bodies, regulatory inspections, and health authority interactions
• Regulatory experience in Europe and the USA; APAC and South America exposure preferred
• Experience working with CMOs, CDMOs, external manufacturers, and suppliers
• Medical Device experience within, biomaterials, fibers, polymers, coatings, or related products preferred
• Strong communication, presentation, technical writing, negotiation, and stakeholder management skills
• Ability to prioritize, work independently, and deliver in a fast-paced environment
• Regulatory Affairs, Clinical Research, Clinical Evaluation, or Quality certifications are advantageous
• Entrepreneurial, hands-on mindset with a high level of ownership and accountability
• Fluent English required;
  German and additional languages are advantageous