Principal Regulatory Affairs Specialist - Global Operations

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:

• 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.

 

Required qualifications:

• 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.

 

Preferred qualifications:

• Strong oral and written communication skills
• Ability to effectively manage multiple projects
• Strong proficiency with Microsoft Excel, Word, PowerPoint, and databases such as PLM

 

 

 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.