- 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.
- 5 – 7 years of medical device, regulatory experience ideally with notified bodies.
- Bachelor's degree, preferably in a scientific or engineering discipline
- Fluent in English (oral and written) with 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 Reg Affairs Specialist - Arden Hills, United States - Boston Scientific
Description
Principal Regulatory Affairs
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.
This position can be worked hybrid from any Boston Scientific location.
Your responsibilities include:
What we're looking for:
Basic 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.
