Description
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. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role
At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work. Global Regulatory Affairs Operations team is looking for a dynamic, well-organized leader who can be a contributing member of a global work environment. This individual will report into the Director/Manager responsible for global regulatory, shared and compliance services.
Your responsibilities will include
- Notified body working group lead on behalf of Global Regulatory Operations (GRO) including but not limited to:
- Plan and lead monthly, quarterly, and annual notified body meetings (BSI, DEKRA, TUV SUD, GMED).
- Support uTrack NB Submission Database (NB Submission Tracker) sustaining activities.
- Lead quarterly uTrack review meetings to review NB Feedback metrics and trends.
- Lead activities related to additions/transfers of notified bodies (including audit support).
- Lead cross-divisional process efficiency initiatives, as needed.
- Influence NB decision process(s), interpretation of regulations, cost management, etc.
- Build strong and trusted business relationships with internal and external partners.
- Own regulatory SOPs and WIs applicable to this role.
- Lead and operate effectively as the GRO regulatory team lead on assigned projects including global regulatory strategy development and execution, notified body submissions, standards support, and advocacy initiatives.
Required qualifications
- Minimum of a bachelor’s degree, preferably in a scientific or engineering discipline.
- Minimum of 10 years of medical device, regulatory experience ideally with notified bodies.
Preferred qualifications
- Master's degree in regulatory affairs.
- Experience in regulatory affairs with a global focus.
- Ability to effectively manage multiple projects.
- Strong written and oral communication skills.
- Strong proficiency with Microsoft Excel, Word, PowerPoint, and databases such as PLM.