Head of RA-QA/PRRC in Zürich

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:

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.

Key Responsibilities

• 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 businessobjectives 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

Profile Requirements

• 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 ClinicalResearch within ISO 13485 environments
• Proven leadership experience in QA/RA, including team management, strategic planning, and stakeholderengagement
• 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, ISO11137, GMP, and global regulatory frameworks
• Experience with regulatory submissions, registrations, product changes, lifecycle management, TechnicalDocumentation, 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

#J-18808-Ljbffr