Fellow Regulatory Affairs Specialist - Merger & Acquisition Integration

Additional Location(s): US-MN-Arden Hills; US-CA-Valencia; US-IN-Indianapolis; US-IN-Spencer; US-MN-Maple Grove; 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.

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.

About the role:

This Regulatory position will be responsible for meeting the Global Regulatory Affairs goals and directions regarding acquisition compliance for all world markets where BSC conducts business. This individual will report into the Global Regulatory Affairs Operations Manager, with a dotted line into the Mergers and Acquisition (M&A) Integration Manager.

Your responsibilities will include:

• Supporting process integration activities including:
  • Identifying regulatory risks/gaps in current processes for new product line needs.
  • Identifying regulatory best practices from acquired company to bring into BSC processes.
  • Maintain cross-functional quality system processes (Labeling, Distribution, etc.)
  • Organizing training sessions for acquired BSC employees to Regulatory and Cross Functional processes
• Support division in Customer to Cash/Distribution Go Live processes to ensure distribution controls are appropriate
• Support division with international communications and interactions (documentation-various media types)
• Support division with site transfers and certificate integrations
• Support division in Legal Manufacturer transitions
• Set regulatory best practices and strategies for the Acquisitions (Wiki/Playbook)
• Regulatory liaison supporting the Acquisition Community of Practice team
• Advisor and SME for due diligence questions
• Develop relationships and potential collaborations across the organization to drive strategic priorities
• Influence decision making through active partnership with cross-functional teams
• Communicate effectively both within immediate team and M&A leadership. Ensure team receives consistent messages and has clear understanding of business direction, strategy, and results.

Required qualifications:

• Minimum of 10 years’ experience in Regulatory Affairs or a combination of experience from related fields (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device industry (preferred countries: USA, EU, Japan, Canada, Australia, China)
• Minimum of a bachelor's degree in quality/regulatory, science, or engineering fields
• Medical Device submission experience: US (PMA (class III) and/or 510k (class II), IDE) and EU MDR

Preferred qualifications:

• Working knowledge of Boston Scientific Regulatory Affairs processes and systems
• Fluent in written and spoken additional language(s)
• Ability to translate technical information into clearly written documents
  

Requisition ID: 561615

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.