Vigilance Manager (gn)

Vigilance Manager EMEA (gn) – Medical Devices / MDR

Hamburg (Hybrid) | 2-year maternity cover via temporary employment (ANÜ) | Start: September 2026

We are looking for our client in Hamburg for a responsible and detail‑oriented Vigilance Manager EMEA (gn). In this role, you will assess medical device events/notifications and decide whether they are reportable to authorities – in a dynamic environment with clear deadlines and close collaboration across several teams.

What we offer:

• Project duration: 2 years (maternity cover), start as soon as possible
• Young, international team with close collaboration
• Structured, intensive onboarding (approx. 6 months) and working under a four‑eyes principle
• Selection process: 1st interview via Teams, 2nd interview on‑site
• Assess and process (potentially) reportable incidents/events for medical devices in line with EU MDR (Regulation (EU) 2017/745) and relevant UK regulations
• Prepare and submit Manufacturer Incident Reports to competent authorities where required and ensure compliance with country‑specific reporting obligations
• Receive and coordinate notifications from the complaint environment, make reportability decisions and align appropriate follow‑up actions
• Coordinate timely responses to information requests from competent authorities
• Explain and defend reportability decisions during audits
• Contribute to process improvements (as internal/external requirements change regularly) and provide updates to management as needed
• Support ad‑hoc tasks and projects

Your profile:

• University degree (e.g. engineering, natural sciences, medicine, law, languages) or a comparable qualification
• Practical exposure to Quality, Regulatory Affairs, vigilance reporting and/or complaint handling is an advantage
• Very good knowledge of EU MDR (Regulation (EU) 2017/745) or the ability to quickly and confidently build up regulatory expertise in a vigilance context; ISO 13485, vigilance reporting and complaint handling are a plus
• Fluent business English; German is a plus
• Careful, structured way of working, sound judgement and the ability to justify decisions in a transparent and traceable manner
• Strong communication skills, resilience and team spirit (working with tight deadlines)

Next steps:

Feel free to contact me so we can discuss open questions and the next steps in the application process.

Phone:

Our job postings are aimed at job seekers of any gender. (gn) = gender-neutral.