Regulatory Affairs Specialist I

1 Month ago • 3 Years +

Job Summary

Job Description

The Corporate Regulatory Affairs LCM department is seeking a Regulatory Affairs Specialist. The RA LCM team maintains IVD products on the market, ensuring regulatory compliance with changes. This role involves evaluating regulatory impacts and managing submissions for product changes, collaborating with production sites and local regulatory teams. Responsibilities include representing RA in project teams, assessing regulatory impacts in registered countries, preparing change files, monitoring submissions, ensuring traceability, integrating new requirements, contributing to RA tools, and maintaining documentation. The role also includes assisting in audits and contributing to working groups.

Must have:

Bachelor’s degree or MS degree
3+ years (BS) or 1+ year (MS) in regulatory affairs, medical device/IVD industry
1+ year experience with FDA

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Job Details

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