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Senior Regulatory Affairs Specialist
vor 3 Monaten
Senior Regulatory Affairs Specialist:
- Remote Eligible: Hybrid
- Onsite Location(s): Dusseldorf, DE
Additional Locations: Germany-Düsseldorf; France-Voisins le Bretonneux; Italy-Milan; Spain-Madrid; United Kingdom-Hemel Hempstead
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.
Location:
All EMEA BSC Hubs
Purpose:
Within the Europe Middle East & Africa (EMEA) Regulatory Affairs organization, the main objectives of the role will be to contribute to successful regional business goals by supporting day to day regulatory activities in the Central Western Europe region, in direct interaction with local regulatory authorities, with a focus on post-market surveillance activities, regulatory support to cross-functional and divisional business units and regional advocacy efforts, this for the entire Boston Scientific product portfolio.
Responsibilities:
- Communication and maintain good relationships with the local regulatory authorities in the region
- Interacts directly with regulatory authorities personnel and coordinate postmarket surveillance activities, for all business units.
- Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on vigilance and other postmarket surveillance matters in the region.
- Manage and execute regulatoryrelated activities associated with field safety corrective actions initiated in the region.
- Support product registrations with regulatory authorities in accordance with product launch plans.
- Provides input and data on regulatoryrelated issues associated with compliance and achievement of the business plan in the region.
- Support tender operations and business units by timely supply of accurate regulatory documentation and information.
- Support regulatory advocacy activities in the region and local medical devices industry trade association.
- Establish and maintain a good working relationship with regional regulatory affairs, crossfunctional partners and business units to gain timely support.
- Serve as regulatory consultant to marketing and sales teams as required.
Qualifications & Experiences:
- Minimum of a Bachelor's degree
- Minimum of 4 years' medical device regulatory affairs experience
- Experience with Post market surveillance activities such as vigilance reporting
- Prior experience leading and/or managing projects
- Excellent written and oral communication in English. German and Dutch language skills are an advantage
- Excellent research and analytical skills
- Ability to manage multiple projects simultaneously
- Ability to collaborate with crossfunctional partners/teams
We offer:
- Competitive salary package
- Permanent working contract
- Flexible working time
- Tailored carrier development plan
Requisition ID:555951
Job Segment:
Regulatory Affairs, Medical Device, Compliance, Law, Supply, Legal, Healthcare, Operations
