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The Corporate Regulatory Affairs LCM (Life Cycle Management) department is looking for a Regulatory Affairs Specialist in a dynamic regulatory context.

The RA LCM team is a major player in the process of maintaining IVDs products on the market, in order to guarantee regulatory compliance with changes made to these products (reagents, instruments and software) in all of the regulated countries in the world.

This team is in charge of evaluating the regulatory impacts and managing the process associated with submissions in the context of product changes, interfacing with the production sites on the one hand, and the local regulatory teams based within the subsidiaries and distributors worldwide on the other hand.

Job Duties

+ Reporting to the LCM RA Manager, your main missions / responsibilities will be:

+ - Be the RA representative in the project team in charge of the change of a product, or a group of products,

+ - Assess the regulatory impact of this change in the countries where this / these product (s) is / are registered,

+ - Prepare the files associated with the changes,

+ - Monitor and follow submissions and interactions with local RA or health authorities until the approval of these changes in support of local regulatory teams,

+ - Guarantee the traceability of regulatory activity linked to the change,

+ - Integrate and implement new local regulatory requirements related to changes,

+ - Contribute to the development of RA tools / Corporate tools and processes related to change management,

+ - Organize, update, and maintain regulatory documentation in accordance with company policy and procedures.

+ - Assist or participate in audits when needed

+ - Contribute to different working groups.

Minimum Qualifications:

+ Bachelor’s degree. Science background is preferred. 3+ years in regulatory affairs, medical device/IVD industry required

+ or MS degree with 1 year in regulatory affairs, medical device/IVD industry required

+ 1+ year experience with FDA