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Principal Regulatory Affairs Specialist
4 months ago
Additional 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 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. 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
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
