PlusOne

Regulatory Affairs Manager - Medtech - Liège

Company

Our clients are startups & SMEs that are regularly looking for RA managers. They usually are companies that focus on the development of innovative solutions such as medical devices to treat headache disorders, or systems to treat severe cardiac diseases, for instance.

Role

Are you interested in participating to the registration activities of a young, innovative company? Would you like to participate in the development of innovative solutions in MedTech? Bringing your expertise in international regulatory affairs is what you are looking for?

Plus One can offer this great challenge!

In this kind of exciting role as RA Manager, you might be responsible for the following:

- Write, edit and review comprehensive regulatory and technical documentation, application dossiers and summaries of technical file.

- Play an active role in the definition of the registration roadmap and timelines to achieve registration strategy globally

- Support cross functional alignment initiatives to ensure compliance on Regulatory and Clinical activities

- Provide technical and product expertise to regulatory and commercial agents for the countries he / she is responsible

- Handle administratively and keep up-to-date registration files, change notification and tenders for the countries he / she is responsible

- Maintain submission and technical documentation, licenses and records up-to-date

- Maintain certification in the countries he / she is responsible

- Ensure documents are produced in accordance with applicable internal and external procedures, guidelines, regulations and standards

- Maintain day-to-day distributor relationships (Regulatory)

- Serve as contact point for regulatory operations in the countries he / she is responsible

- Report on registrations performance and progress

Profile

- MSc (or higher) degree in a technical or science discipline

- General knowledge of medical device regulations and Quality Management Systems

- Good knowledge of the MDR

- Relevant experience within regulatory function in medical devices industry

- Sense of responsibilities and ownership

- Ability to work across function and in a changing international environment.

- Strong oral and written communication skills in English

Offer

Our clients offer a challenging and diversified position in a dynamic and ever evolving start-up atmosphere! You would have the chance to get involved in the evolution of a human size company.

Our clients are startups and SMEs active in Biotech, Medtech and Hightech. They generally offer opportunities in a very dynamic and fast-growing environment!

How to apply ?

If you are interested in this type of challenging opportunities, please address your application to our recruitment team office@plusonesearch.be or directly on www.plusonesearch.be

Publication date

17.09.2022

Contact person

Dion

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