Fellow, Regulatory Affairs

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: 

Regulatory Subject Matter Expert (SME) on multiple products, technologies and regions.   Devotes a significant portion of time to leadership at both the franchise level and functional level, including department employee development responsibilities.

Work Mode:
At Boston Scientific, we value collaboration and synergy. This role has a hybrid or remote work model and will require travel to associated meetings and project-related events. This role follows a remote work model.

Relocation:
Relocation assistance is not available for this position at this time.

VISA:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

• Provides regulatory expertise with respect to global commercialization strategy development, execution and risk management
• Participates in advocacy/outreach with Sr. franchise and functional leaders to achieve Urology business objectives and assess commercialization pathway trade-offs
• Provides regulatory expertise to facilitate entry into new therapeutic areas, technologies and design; and new regulated regions such as emerging markets
• Drives clarity into product approval and post market requirements through effective problem identification, communication and use of regulatory agency network 
• Operates effectively as regulatory team lead on assigned projects including global regulatory strategy development and execution
• Assesses and manages global dependencies and opportunities to coordinate regulatory efforts serving as liaison to both regional BSC RA personnel and Agencies, and internal functional and program management stakeholders
• Capable of authoring and executing / supporting all aspects of Global Regulatory Strategies
• Supports New Business Development by performing regulatory due diligence on candidate companies and products/programs; provides initial regulatory project management for integration of new companies and products into the Urology divisional structure; acts as RA Core Team Member PDP programs 
• Leads regulatory-related education efforts and mentoring in areas of expertise
• Studies and understand applicability of relevant regulations to the business
• Researches competitive product regulatory approvals and pathways, and disseminates to relevant stakeholders 
• Supports Quality System and audit readiness through maintenance and provision of regulatory information to QA, Notified Bodies and FDA
•  

Required qualifications:

• Minimum on 8 years of experience with a BA degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines.

Requisition ID: 624712

Minimum Salary: $131700 

Maximum Salary: $250200 

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 identity, 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.