- 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
-
Sr. Regulatory Affairs Specialist
5 days ago
Boston Scientific Corporation Arden Hills, United StatesUnder minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position Regulatory Affairs, Specialis ...
-
Sr. Regulatory Affairs Specialist
1 week ago
Boston Scientific Arden Hills, United StatesAdditional Location(s): N/A · 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 ...
-
Sr. Regulatory Affairs Specialist
1 week ago
Boston Scientific Arden Hills, United States Regular, Full timeAdditional Location(s): N/A · 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 s ...
-
Principal Reg Affairs Specialist
3 weeks ago
Boston Scientific Arden Hills, United States Regular, Full timeRecruiter: Spencer Gregory Hale · Principal Reg Affairs Specialist · About the role: · At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregula ...
-
Principal Regulatory Affairs Specialist
1 week ago
Boston Scientific Arden Hills, United States Regular, Full timeAbout 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 ...
-
Principal Reg Affairs Specialist
1 week ago
Boston Scientific Arden Hills, United States Regular, Full timeRecruiter: Lukas Daniel Richardson · About the role: · At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work.In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure ...
-
Principal Reg Affairs Specialist
3 weeks ago
Boston Scientific Arden Hills, United StatesPrincipal 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 c ...
-
Principal Regulatory Affairs Specialist
5 days ago
Boston Scientific Arden Hills, United StatesAdditional Location(s): N/A · 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 ...
-
Principal Regulatory Affairs Specialist
2 weeks ago
Boston Scientific Arden Hills, United StatesAbout 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 ...
-
Principal Regulatory Affairs Specialist
5 days ago
Boston Scientific Arden Hills, United States Regular, Full timeAdditional Location(s): N/A · 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 s ...
-
Regulatory Affairs Specialist
1 week ago
3M Saint Paul, MN, United StatesJob Description:Regulatory Affairs SpecialistCollaborate with Innovative 3Mers Around the WorldChoosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, a ...
-
Regulatory Affairs Specialist
1 day ago
Insight Global St Paul, United States Full timeLocation: St. Paul, MN - remote to start, but will transition to a hybrid model in the coming monthsContract: 3-12 month contract to likely hirePay: $ /hrOpenings: 1Must-haves Bachelors Degree in chemistry, biology, or other scientific/technical discipline · Database management s ...
-
Senior Regulatory Affairs Specialist
1 week ago
Laborie Plymouth, United StatesWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like ...
-
Sr. Regulatory Affairs Specialist
4 days ago
Taleo Minneapolis, United StatesPosition Description:Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapi ...
-
Sr. Regulatory Affairs Specialist
5 days ago
Taleo Minneapolis, United StatesPosition Description: · Sr. Regulatory Affairs Specialist for Medtronic, Inc. · Minneapolis, MN. Multiple positions available. · Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products an ...
-
Sr. Regulatory Affairs Specialist
1 week ago
Medtronic Minneapolis, United StatesPosition Description:Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapi ...
-
Senior Regulatory Affairs Specialist
1 week ago
Laborie Minneapolis, United StatesWe believe that great healthcare is an essential safeguard of human dignity. At Laborie, we know the work we do matters its what fuels our motivation and contributes to our success. If youre ready to make a positive impact in the lives of patients across the globe, wed like to me ...
-
Sr. Regulatory Affairs Specialist
5 hours ago
Medtronic Minneapolis, United StatesPosition Description:Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapi ...
-
Sr. Regulatory Affairs Specialist
1 day ago
Medtronic Minneapolis, United StatesPosition Description: · Sr. Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and ther ...
-
Senior Regulatory Affairs Specialist
1 day ago
Laborie Minneapolis, United StatesWe believe that great healthcare is an essential safeguard of human dignity. · At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd li ...
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 specificprohibited substancetest 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.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
