Senior Specialist Regulatory Affairs And Quality Assurance

Senior Specialist QA/RA
Zurich, Switzerland · Full-time 100% · Hybrid · Quality & Regulatory

Join our two-person Quality Assurance and Regulatory Affairs team, reporting to the Head of QA/RA. You will work across quality assurance, regulatory affairs, and operational quality: building ISO 13485, FDA QMSR, and EU MDR requirements into our quality management system, supporting submissions in the US, Switzerland, and the EU, and making sure the records behind every build hold up in an audit. You will work day-to-day with Engineering, Clinical Affairs, and Operations at The Gallery (Glattbrugg-Opfikon).

What you will do

• Build ISO 13485, FDA QMSR, and EU MDR requirements into our existing QMS: draft, review, and update SOPs, work instructions, templates, and records.
• Lead and support CAPAs, and take part in deviation, nonconformity, and change-control processes.
• Support and participate in internal and external quality audits.
• Run supplier quality activities, including supplier evaluation and qualification.
• Support regulatory submissions and registrations in the US, Switzerland, and the EU.
• Assess the regulatory impact of product and process changes.
• Participate in product and process risk management, design reviews, and documentation reviews.
• Review and verify quality control reports and records: check completeness and compliance with internal requirements, and identify deviations and nonconformities.

What success looks like in your first year

• You run the day-to-day QMS work: document control, CAPAs, deviations, and change control. Our supplier files are audit-ready. You have contributed to our US and EU regulatory submissions and taken part in at least one internal or external audit.

Required

• A Bachelor's or Master's degree in a life science, engineering, or related field.
• 3+ years in quality assurance and regulatory affairs at a medical device company.
• Thorough knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 (QMSR), and EU MDR 2017/745.
• A solid understanding of FDA requirements and the EU MDR in practice.
• Experience conducting internal and external audits and supporting regulatory inspections.
• You collaborate well across functions and with stakeholders of very different expertise.
• Good communication skills and a problem-solving approach.
• A pragmatic, collaborative, and proactive mindset.
• Fluent English — our working language across the whole team.
• Authorization to work in Switzerland.

Bonus

• Class III or active medical device experience.
• Hands-on experience with an FDA IDE or EU MDR technical documentation.
• Experience with an eQMS such as Greenlight Guru.

Our offer

• A verified proof point: Apersys is built on the Liver4Life program that performed the world's first multi-day human liver transplantation.
• A regulatory tailwind: FDA Breakthrough Device Designation, an active Early Feasibility Study path with leading US transplant centers, and EU MDR execution in parallel.
• A role with real breadth: quality assurance, regulatory affairs, and operational quality for a Class III medical device, in a small team where your work goes straight into submissions and audits.
• A senior, interdisciplinary team of surgeons, perfusionists, engineers, scientists, and operators.
• Zurich, hybrid where the work allows. BVG pension, accident and illness insurance, family-friendly leave, participation in the Employee Stock Option Program, and our new office at The Gallery (Thurgauerstrasse 119, 8152 Glattbrugg-Opfikon), between Zurich Airport and Oerlikon station.
• Our perfusion system is an investigational device and is not yet cleared or approved for commercial use.