Medical Device Regulatory Affairs Consultant - Bavaria

We are on the lookout for Medical Device VETERANS! Do you want to use your hard-earned expertise to consult on projects which you're passionate about? Come join our highly prestigious team, which is well respected across the medical devices industry.

We want you to work on these projects and advise our clients on various aspects of the development of drug-device combination products. Aid in the rapid innovation within the Medical Devices industry and see how the work you do makes history. Ideally you are a medical device expert with a strong background in regulatory affairs.

The role of a consultant can vary depending on which project they're working on. Due to this we have made a list of various tasks and requirements. Please be advised that we do not expect you to be able to perform every single task and have every single requirement. They are just a guideline on the type of profile we are looking for.

Tasks and 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.

Give expert level advice to clients on various aspects such as technical, quality and clinical with a focus on combination product development while collaborating with cross-functional experts from our team of veterans.

Ensure the content within medical device work-packages and documents are appropriate

Ensure CE certification and also perform the gap analyses for regulatory compliance

Support Notified Body submissions (including NBOp as per MDR Art. 117, clinical investigation, 510(k) to the FDA)

Prepare the device-related module-3 sections for both MAA and BLA/NDA submissions of drug-device combination products which are regulated as medicinal products

Conduct meetings, together with the client, with Notified Bodies and FDA with briefing packages which you have prepared.

Manage both the strategical and operational aspects with CMOs

Requirements:

Ph.D. or master's degree and at least five years of experience in the field

Experience with regulatory filings is a MUST

In depth understanding of medical devices

Experience with medical devices (doesn't have to be drug-device combination products) and regulatory requirements for all device life-cycle stages

Fluency in both written and spoken English is a MUST

Willing to be in the office in Bavaria at least 3 days a week is a MUST

We offer:

Relocation support such as assistance with finding accommodation, permits, schools for children etc

Training for parts of the job description in which you don't have experience

A highly-social working environment

Flexibility in working hours

Flexibility in choosing which projects you want to work on

Expanding company which provides stable employment

Highly competitive salary

For more information please reach out to the responsible recruiter: Mr. Billy O'Brien

Phone: 0049 892 109 3369

E-Mail: b.obrien@nonstop-recruitment.com

Linked in: https://www.linkedin.com/in/billy-o-brien-07317123a