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.
Salary:
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.
Company:
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.
Location:
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
Your Background:
- 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.
Apply:
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
