My client, a global growing Medical Devices company is currently looking for a Regulatory Affairs Expert with strong experience within Vigilance activities join one of their office in Iles de France.
Provide input on regulatory-related issues associated with compliance and achieving the business plan.
Ensure that registration/licenses are maintained with the local regulatory authority in accordance with national requirement.
Prioritize and plan on product notification for his respective product lines according to launch plans, including product changes.
Review and approve promotional and advertising materials to ensure compliance with Corporate policy and national laws.
Prepare, coordinate and submit responses to questions received from the regulatory authority on post-market surveillance matters.
In collaboration with clinical, marketing and project teams, prepare and submit the documentation required for clinical investigations planned in the region
Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
Establish and implement plans to maintain a trusted relationship with the local regulatory authority.
Influence the local regulatory authority using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
Support tender operations by timely supply of accurate regulatory documentation and information as required.
Establishes relationships with local medical device industry groups and works with industry peers to influence regulatory issues and local policies.
Establish and maintain a good working relationship with regional regulatory peers to gain positive and timely support.
Serves as regulatory consultant to internal cross-functional teams, at national and Corporate level
Ensure compliance with internal Quality system and policy training requirements and complete within defined timeline.
3-5 years in a similar position, ideally in the Medical Device industry or in pharmaceutical industry. Solid understanding of post-market surveillance requirements and the role of CE Authorised Representative under the Medical Devices Directives is a plus
Demonstrates experience interacting with the French regulatory agency and participating in French industry trade association.
Fluent French and English
Knowledge of the CE marking environment
Mandatory experience in ensuring compliance with French Advertising Law applicable to Health Care products
Experience in post-marketing vigilance
Excellent facilitation skills (for instance in meetings with regulatory agencies)
Experience in Clinical study submissions would be appreciated
For more information please contact Noemie Oliva at email@example.com