- Notified body working group lead on behalf of Global Regulatory Operations (GRO) including but not limited to:
- Lead monthly, quarterly, and annual notified body meetings (BSI, DEKRA, TUV SUD, GMED)
- Support uTrack NB Submission Database (NB Submission Tracker) sustaining activities
- Host quarterly uTrack review meetings to review NB Feedback trends
- Support activities related to addition/transfer of notified body (including audit support)
- Project Manage cross-divisional process efficiency initiatives, as needed
- Own regulatory SOPs and WIs applicable to this role
- Operate effectively as the regulatory team lead on assigned projects including global regulatory strategy development and execution, notified body submissions, standards support, and advocacy initiatives.
- Minimum of a bachelor's degree, preferably in a scientific or engineering discipline
- Minimum of 7 years of medical device, regulatory experience ideally with notified bodies.
- Strong oral and written communication skills
- Ability to effectively manage multiple projects
- Strong proficiency with Microsoft Excel, Word, PowerPoint, and databases such as PLM
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Principal Regulatory Affairs Specialist - Arden Hills, United States - Boston Scientific
Description
About the role:
At Boston Scientific, you'll discover a place where you can find meaningful purpose, improving lives through your life's work. The Global Regulatory Affairs Operations team is looking for a dynamic, well-organized individual who can be a contributing member of a global work environment. This individual will report into the Manager responsible for global regulatory, shared and compliance services.
Your responsibilities will include:
Required qualifications:
Preferred qualifications:
Requisition ID: 582041
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
