CK Group are recruiting for a Medical Device Regulatory consultant to join a international regulatory affairs consulting business, based in Munich, Germany on a full time permanent basis.
Everyone says "negotiable" or "competitive", but in this case it truly is! For a candidate with the right skills and experience, we can be competitive and offer a rewarding salary & package. When you apply, please quote your current package and expectations.
Our client is an established consulting business in the field of regulatory affairs. The staff of experienced consultants have built a strong reputation for excellence, and the company is looking to bring in additional staff to supplement the existing team.
Munich, Germany. It is expected that you will work from the offices 60% of the time ~3 days per week.
Medical Device Regulatory Consultant:
The Consultant ?Medical Device? supports the device parts of drug-device combination products, In Vitro diagnostics and companion diagnostics in a drug development environment.
Tasks & Responsibilities:
- Provide advice to clients on technical, quality, clinical aspects of drug-device combination product development in close collaboration with cross-functional experts from the team.
- Ensure that content of medical device work-packages and documentation are appropriate and enable CE certification and perform gap analyses for regulatory compliance.
- Support Notified Body submissions (including NBOp as per MDR Art. 117, clinical investigation, 510(k))
- Preparation of device-related module-3 sections for MAA and BLA/NDA submissions of drug-device combination products regulated as medicinal products
- Prepare briefing packages for meetings with Notified Bodies and agencies and conduct such meetings together with the client
- Management of operational and strategical aspects with CMOs
- Ph.D. or master?s degree and at least five years experience in the field including experience in drug development
- Experience with regulatory filings (technical documentation for CE-certification & STED/application for clinical investigations/pre-RFD/RFP/IDE/De Novo/510(k)/PMA)
- In depth understanding of medical devices (MDR, IVD, IVDR; 21 CFR Part 820) and QA (ISO 13485)
- Experience with medical devices and regulatory requirements for all device life-cycle stages and with relevant processes including risk management and usability engineerin
- Team player with strong interpersonal abilities and excellent communication skills in English.
Please quote job reference 55252 in all correspondence.
You must have the right to work in Germany.
- Agency: CK Group
- Reference: 55252
Website: CK Group
- Posted: 15th March 2023
- Expires: 12th April 2023