Senior Regulatory Affairs Specialist (FDA experience mandatory)

Description

Critères de l'offre

Critères de l'offre

Our client is an international company specialized in medical devices.

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Provide Regulatory strategies for projects as RA representative in cross-functional teams
Responsible for regulatory Assessment on product changes
Coordinate the preparation of regulatory submissions (such as IDE, original PMA and supplements)in the context of new product and product changes in accordance with FDA requirements
Coordinate the responses to questions raised by FDA
Review of product labelling
Participate in audits and inspections, ensuring compliance with FDA requirements
Stay up-to-date with relevant regulations, guidelines, and industry trends, and provide strategic regulatory guidance to internal stakeholders
Ensure accurate population of RA databases
Maintain and update SOP's for Regulatory department

Minimum 7 to 10 years of experience in Medical device or pharmaceuticals industry
Proficient knowledge of quality standard (ISO 13485) and relevant regulations (21CFR part 820, MDR 2017/745) and appropriate laws, guidelines and industry standards Demonstrated experience in communicating with regulatory agencies including FDA and UE regulatory agencies
Demonstrated experience in leading, writing and submission of complex regulatory filling(e.g. IDE, PMA, CE mark, etc-)
Demonstrated ability in analytical reasoning and critical thinking skills
Good knowledge of relevant regulations (FDA)
Ability to work on several projects simultaneously, ability to prioritize
Fluent in English with at least a B2 level in French