My client is looking for a Senior Regulatory Manager (Biocompatibility) based in Baden-Württemberg.
A great opportunity to join a fast-growing company with a great portfolio of products and clients.
Senior Regulatory Manager (Biocompatibility)
Salary: Up to 120,000€
- Compiling scientific statements on the biocompatibility of medical devices in a regulated environment
- Meeting the MDR requirements focusing on biocompatibility as part of a risk management process
- Being involved in development, checking, and writing Biocompatibility report
- Preparation of technical documentation according to MDR with focus on substance-based medical devices or combination products
- Close cooperation with international notified bodies and competent authorities
To be considered you need to have:
- Eligibility to work in Germany
- Life Sciences education
- 4+ years Regulatory affairs experience within Medical devices industry
- 3+ years’ experience in Biocompatibility
- Very good written and spoken English skills
- German professional level highly desirable
Looking but this isn’t the right position for you?
If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV and the best time for a call to to setup a confidential discussion about potential opportunities.
Regulatory / RA / Medical / devices / 13485 / MDR / MDD / Biocompatibility / 10993 / technical / Files / documentation / risk / management /
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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