Consultant | Medical Devices | QARA United States & Europe🔠Quality & Regulatory Affairs Manager – Class III Cardiovascular Devices 🫀 Company Type: Clinical-stage medical device developer focused on structural heart therapies We’re partnering with an emerging German MedTech company developing a catheter‑based Class III implant for structural heart repair. The device targets a major unmet need in minimally invasive heart valve therapy and is on track for pivotal trials. The company is now hiring a QA/RA Manager to take ownership of its Quality and Regulatory function. This is a high‑trust role, reporting directly to the Managing Director, and acting as the Quality Management Representative and Person Responsible for Regulatory Compliance. Quality Management Lead day‑to‑day QMS operations (ISO 13485:2016, 21 CFR Part 820, MDSAP) Create, review, and maintain SOPs; lead employee training on GMP, GDP, and internal processes Organize internal and supplier audits; ensure compliance with global standards Oversee incoming inspections, labeling, inventory, and device safety testing Investigate non‑conformances and complaints, manage CAPAs and preventive actions Liaise with Clinical and R&D teams to support project compliance Regulatory Affairs Manage regulatory strategy and submissions for EU MDR and US FDA (Class III) Prepare technical documentation and V&V input alongside R&D Coordinate with application engineers and customers on documentation and compliance needs Lead interactions with Notified Bodies, FDA, and other authorities 5+ years of QA/RA experience in a regulated MedTech setting (Class III preferred) Strong working knowledge of ISO 13485, MDR, 21 CFR Part 820, and MDSAP Direct experience with regulatory submissions (EU and/or US) Proactive, detail‑driven, and comfortable in lean environments Fluent in English; German is advantageous Background in cardiovascular or structural heart is a plus Confident acting as QMR/PRRC and representing the company during audits Why This Role Is Attractive Strategic ownership: Full responsibility for QA/RA and QMS compliance Flat reporting: Direct line to the Managing Director Purpose‑driven product: Implant targets a critical area in cardiac care Stable & clinical‑ready: Device is Class III and approaching regulatory milestones On‑site collaboration: Join a tight‑knit, hands‑on team at the heart of development Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Skills Alliance by 2× #J-18808-Ljbffr