Head of RA-QA/PRRC

ph3Head of RA/QA /h3 pMy 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. /p ul liEmployment Type: long term Permanent Employment /li liLocation: Zürich (Hybrid) /li liStart Date: /li /ul pOverview 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. /p h3Key Responsibilities /h3 ul liLead and develop the global QA/RA function, including team management, coaching, and strategic leadership /li liDefine and execute the Quality Assurance and Regulatory Affairs strategy, ensuring alignment with businessobjectives and growth plans for existing and new product registrations /li liAct as the Person Responsible for Regulatory Compliance (PRRC) or ensure fulfillment of PRRCresponsibilities in accordance with EU MDR 2017/745 /li liOwn the Quality Management System (QMS), regulatory compliance, audits, inspections, CAPA processes,and continuous improvement initiatives /li liEnsure compliance with FDA, EU MDR, ISO standards, GMP requirements, and other applicable globalregulations /li liLead regulatory submissions, product registrations, product changes, market approvals, and lifecyclemanagement activities across Europe, USA, Asia-Pacific, and South America /li liEnsure ongoing compliance for products already on the market and support international market expansion /li liLead cross-functional collaboration with RD, Manufacturing, Quality Control (QC), Clinical, Commercial,Quality Engineering, and external partners including CMOs and CDMOs /li liAct as the primary contact for regulatory authorities, notified bodies, auditors, and key external stakeholders /li liDrive quality, manufacturing, and operational improvement initiatives to ensure product quality, compliance,and scalable business growth /li /ul h3Profile Requirements /h3 ul liAdvanced degree (Master's, PhD, or equivalent) in Life Sciences, Biomedical Engineering, Natural Sciences,or a related field /li li5-10 years of Medical Device experience across Regulatory Affairs, Quality Assurance, and/or ClinicalResearch within ISO 13485 environments /li liProven leadership experience in QA/RA, including team management, strategic planning, and stakeholderengagement /li liPRRC experience or eligibility under EU MDR 2017/745 /li liStrong knowledge of EU MDR 2017/745, FDA 21 CFR Part 820, ISO 13485, ISO 14971, ISO 10993, ISO11137, GMP, and global regulatory frameworks /li liExperience with regulatory submissions, registrations, product changes, lifecycle management, TechnicalDocumentation, QMS, CAPA, and post-market compliance /li liExperience managing FDA audits, notified bodies, regulatory inspections, and health authority interactions /li liRegulatory experience in Europe and the USA; APAC and South America exposure preferred /li liExperience working with CMOs, CDMOs, external manufacturers, and suppliers /li liMedical Device experience within, biomaterials, fibers, polymers, coatings, or related products preferred /li liStrong communication, presentation, technical writing, negotiation, and stakeholder management skills /li liAbility to prioritize, work independently, and deliver in a fast-paced environment /li liRegulatory Affairs, Clinical Research, Clinical Evaluation, or Quality certifications are advantageous /li liEntrepreneurial, hands-on mindset with a high level of ownership and accountability /li liFluent English required; German and additional languages are advantageous /li /ul /p #J-18808-Ljbffr