Fellow, Regulatory Affairs

Additional Location(s): US-MN-Maple Grove

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: 
As the Regulatory Affairs Functional/Integration Lead, you will play a key role in the successful integration of new products into Boston Scientific. You will devote a significant portion of time to planning, communication, and leadership at executive and team levels. As well, you will collaborate across functions, sharing your RA technical knowledge and influencing key stakeholders on the most efficient regulatory pathway toward business growth. This role reports to the Director, Regulatory Affairs and is a hybrid position (in office minimum three days per week) located in Maple Grove, MN.

Your responsibilities will include: 

• Leading and managing the RA functional interactions and engagement for the integration project, collaborating with the Project Manager and other functional leads/team members
• Conducting integration activities, such as:
  • Identifying regulatory risks/gaps in current processes needed for new products and potential impact to timeline targets
  • Evaluating regulatory best practices from acquired company to bring into BSC 
  • Facilitating Customer to Cash/Distribution Go Live processes, ensuring product distribution controls are appropriate 
  • Legal Manufacturer transitions, certificate integrations, and site transfers as applicable
• Communicating effectively with the immediate Integration team, Leadership, and other stakeholders. Ensure consistent messages and clear understanding of business direction, strategy, and results
• Serving as an advisor and SME for ongoing due diligence/integrations across the RA organization
• Developing relationships and collaborations which may drive efficiencies, growth, and strategic priorities
• Influencing decision making through active partnership with key leaders and cross-functional teams 
• Executing regulatory submissions as needed for remediation or other business needs

Required qualifications: 

• Minimum of a bachelor’s degree 
• Minimum of 10 years' experience in Regulatory Affairs or a related discipline (e.g. Quality, R&D, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries
• Strong knowledge of regulatory submission requirements, including US Class III device/PMA experience
• Previous experience on a major product/program, ideally within a functional lead or project manager role
• Ability to travel up to 20%

Preferred qualifications: 

• Experience with Combination products highly preferred
• Experience with US Class II devices/510(k), acquisitions/integration or due diligence, pharma, and/or software applications
• Highly effective communicator with ability to influence and engage teams on regulatory strategies
• Experience working in complex matrixed organizational structures with demonstrated capability to collaborate and influence across such an organization
• Provides a sense of confidence to the organization and can articulate sound regulatory rationales
• Adaptability, comfortable proposing alternate approaches, and ability to work in a fast-changing environment 
• Excellent communication skills across all levels with ability to transfer knowledge efficiently and effectively
• Demonstrated high degree of integrity, professionalism, and the ability to establish credibility
• Sense of urgency, responsiveness, and commitment to execution

#LI-Hybrid

 Requisition ID: 597531

Minimum Salary: $118500 

Maximum Salary: $225200 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.