Senior Regulatory Affairs Specialist

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.       

Are you interested in working on cutting edge technologies in the fast-paced cardiovascular medical device space?  At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. This is a place where you can find a career with meaningful purpose - where we value diversity, ensure everyone’s voice is heard and respected, and prioritize initiatives that promote awareness and celebrate personal, cultural, and demographic differences of our customers, patients, and workforce.

About The Role
We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position supporting exciting sources of growth for Boston Scientific.  This candidate will help drive direction from the core team level and provide strategic inputs to RA senior leadership.   We are looking for a future regulatory leader with a problem-solving mentality and a strong desire to identify, comprehend, and assimilate knowledge across regulatory, engineering, and clinical disciplines. This position will be a key contributor in the global regulatory facilitation of design enhancements, next-gen devices, MDR compliance, and clinical strategy within BSC’s Coronary Therapies Franchise.  

This is a hybrid role (in office 3 days per week) based in Maple Grove, Minnesota. 

Your responsibilities will include:

• Develops and implements regulatory strategies for new and modified products
• Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions
• Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Works cooperatively with R&D, process development, quality, manufacturing, biocompatibility, clinical, and marketing on complex projects to ensure success
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Tracks key competitive technologies and provides regulatory assessment in collaboration with new business development and marketing in order to gain alignment with franchise stakeholders
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams

Required Qualifications:

• Bachelor’s degree in a scientific or technical discipline, preferably a BS or MS in Engineering or Biological Sciences
• 5+ years Medical Device Regulatory Affairs experience, or 1+ years Medical Device Regulatory Affairs experience and 5+ years of experience in a related discipline within the medical device industry (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) 
• Thorough understanding of US and EU medical device regulations
• Thorough understanding of product development process and design controls
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs
• Demonstrated ability to manage multiple regulatory projects, as well as serve as regulatory lead on projects
• Strong technical knowledge of medical devices, procedures, practices, and related terminology

Preferred Qualifications:

• Experience in interventional cardiology, strong clinical acumen, experience with PMDA submissions (JP)
• Comprehensive understanding of medical device standards and guidance
• Excellent research and analytical skills
• Excellent organizational, communication and collaboration skills. Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
• Strong leadership, interpersonal and influencing skills
• Ability to work independently with minimal supervision, as well as mentor/guide others
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)

#LI-Hybrid

Requisition ID: 609227

Minimum Salary: $82600 

Maximum Salary: $156900 

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.