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Principal Regulatory Affairs Specialist - Sterilization

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Maple Grove; US-MA-Marlborough; US-MN-Minneapolis; US-MN-Minnetonka

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.  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 sterilization, shared and compliance services.


Your responsibilities will include: 

  • Lead sterilization change efforts for EU on behalf of all divisional RA teams including but not limited to:
  • Creating regulatory strategy to gain approval for sterilization initiatives 
  • Authoring and submitting MDD and EU MDR submissions for sterilization changes.
  • Support and draft EU sterilization Notified Body (NB) questions and correspondence
  • Monitoring of sterilization regulatory changes and ensuring company readiness
  • Providing consultation on sterilization interpretations and RA impact to all stakeholders
  • Broaden role to include sterilization expertise in all markets outside of USA/EU
  • Regularly interaction with all Sterilization SMEs, Global RA Ops team members, sterilization project members, and periodically with Divisional and/or Country RA representatives
  • Project Manage cross-divisional and/or pan-regional process efficiency initiatives, as needed
  • Support the Product Approval pillar and quality system Steward activities
  • Own regulatory SOPs and WIs applicable to this role


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 EU submissions
  • Experience and knowledge in medical device sterilization Ethylene Oxide (EO) and Radiation methods


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: 558586

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 drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), 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.




Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Compliance, Medical Device, Law, PLM, Legal, Healthcare, Management

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