Medical Device Consultant - Regulatory affairs

Location United Kingdom
Salary: £90000 to £999999
Contact name: Jack Watterson-Burnell

Contact email: jack@medella.life
Job ref: 529
Published: 28 days ago

Medical Device Consultant – Germany

I am currently recruiting for a leading Regulatory consultancy based in Germany, searching for an experienced regulatory professional with experience in the medical device space.

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

Requirements:

• 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 engineering

• Team player with strong interpersonal abilities and excellent communication skills in English.