Additional Location(s): US-MA-Marlborough
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 find purpose through your life’s work—improving lives with innovative medical solutions. Within our Endoscopy division, we develop and deliver advanced technologies that diagnose and treat diseases of the digestive system, airway, and lungs. Our portfolio includes solutions in balloon dilation, stenting, ERCP/cholangioscopy, biliary, biopsy and polypectomy, hemostasis, endobariatrics, radiofrequency ablation, and enteral feeding.
This role in Regulatory Affairs will be responsible for developing regulatory strategies and providing support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The ideal candidate brings experience across U.S., EU, China, and other international markets to support expansion efforts and ensure global compliance.
We continue to invest in innovation across both established platforms and new pipeline development. As a Senior Regulatory Affairs Specialist, you will play a key role in supporting the global regulatory strategy for our Endoscopy product lines—from new product introductions to sustaining and post-market activities.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities will include:
● Develop and implement regulatory strategies for new and modified medical devices
● Provide regulatory guidance for OEM and Contract Manufacturer partnerships
● Act as a liaison for new business partners on US, EU, China, and international product registration
● Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
● Draft and submit U.S. and EU regulatory filings for new and modified medical devices
● Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
● Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
● Support associated global submissions in accordance with applicable regulations
● Represent the company in communications with regulatory agencies regarding submission strategy, testing requirements, and follow-up during review
● Support and maintain Boston Scientific's Quality initiatives in accordance with our Quality Policy
● Continuously identify and support opportunities for quality improvement across the organization
Qualifications:
Required qualifications:
● Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
● Minimum of 4 years' experience in Regulatory Affairs within the medical device industry
● Strong working knowledge of FDA, EU MDR, and international medical device regulations
● Prior experience with 510(k) submissions
● Prior experience with EU MDR
● Prior experience with China and international regulatory requirements
● General understanding of product development and design control processes
● Familiarity with regulations related to the conduct of clinical trials
● Fluent in Mandarin
Preferred qualifications:
● Experience preparing and submitting 510(k), PMA, IDE, EU MDR, or international registrations
● Proficiency with Microsoft Office tools
● Strong analytical, research, and problem-solving skills
● Excellent written and oral communication, technical writing, and editing abilities
● Demonstrated ability to work independently with minimal supervision
● Ability to manage multiple regulatory projects simultaneously
Requisition ID: 621939
Minimum Salary: $89200
Maximum Salary: $169500
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.
Boston Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
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Retirement Support — Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
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Leave & Time Off Breadth — Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.
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What We Do
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.
