5 months ago
My client, a Global Medical devices company are looking for a Senior RA Specialist in Software Medical Devices based in South West Germany.
A great opportunity to join a fast-growing company with a great portfolio of products and clients.
Senior RA Specialist in Software Medical Devices
Location: South West Germany (home working can be flexible)
Salary: Up to 110,000€
Global Medical devices company
- Compilation of tech files
- Implementing QMS to ISO 134585 or MDSAP
- Close interaction with international Notified Bodies and Competent Authorities
- Setting up risk management
- Right SOPs for QMS
- Being responsible for leading projects
To be considered you need to have
- Eligibility to work in Germany
- 5+ years’ experience in medical devices industry
- 5+ years’ experience in Regulatory Affairs
- Profound knowledge in 62304 and MDSW CE marking
- 510(k) experience (desirable)
- English mandatory
- German (desirable)
- 60601 experience (desirable)
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Catalyst Life Sciences
CLS are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets.
- Pre-clinical Development & Safety
- Clinical Development
- Medical Affairs & Information
- Regulatory Affairs
- Pharmacovigilance/Drug Safety
- Quality & Validation
My Linked In Profile
I personally specialise in recruiting QA, RA and validation professionals for roles across DACH so please do get in touch should you be considering new roles or looking to fill ones at your current company!
RA / regulatory / MDD / MDR / devices / 13485 / submission / regulatory / FDA / CFR / 21 / MDSAP / 62304 / project / manager / CE / marking / QMS / SOP / technical / files / documentation / Risk / medical / software