Principal Regulatory Affairs Specialist

Boston Scientific Gruppe; Maple Grove (MN); On-site; USD 102,000 - 194,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific seeks a Principal Regulatory Affairs Specialist to support the Interventional Oncology and Embolization division in a hybrid work model. The role focuses on ensuring global regulatory compliance for post-market activities including PIRs, CAPAs, recalls, NCEPs, and audits.

You will collaborate with regulatory partners worldwide, lead regulatory documentation, and guide cross-functional teams on post-market activities while staying current on evolving requirements.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• Minimum 5 years of Regulatory Affairs/Quality in medical devices.
• EU MDR knowledge and global regulatory exposure.
• Experience managing PIRs, CAPAs, recalls and audits.

Responsibilities

• Serve as Regulatory Affairs specialist and coordinate recalls with Field Action Team.
• Liaise with U.S. and international regulatory bodies for recalls and PIRs.
• Develop and monitor CAPAs to address nonconformances and drive improvement.
• Support audits and regulatory activities across functions.

Skills

Regulatory affairs

Quality management

Cross-functional collaboration

Regulatory guidance

Education

Bachelor's degree in science/engineering

Advanced degree (preferred)

Tools

Microsoft Office

Adobe Acrobat

Job description

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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:

We are seeking a highly skilled and experienced Principal Regulatory Affairs Specialist to join our Interventional Oncology and Embolization division. In this role, you will play a pivotal role in supporting global regulatory compliance across key post-market activities, including Product Incident Reports (PIRs), Corrective and Preventive Actions (CAPAs), recalls, Nonconforming Events and Prevention (NCEPs), and audits.

You will apply your knowledge of global regulatory requirements while collaborating with cross-functional teams and regulatory partners to support compliance, continuous improvement and effective regulatory execution.

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

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:

• Serve as a Regulatory Affairs specialist and collaborate with the Field Action Team on product corrections and recalls.
• Manage communications with internal regulatory partners outside the U.S. and external regulatory bodies regarding recalls.
• Coordinate and manage Product Incident Reports (PIRs), including investigation, documentation and reporting to regulatory authorities.
• Develop and monitor Corrective and Preventive Actions (CAPAs) to address nonconformances and support continuous improvement within the divisional Regulatory Affairs group.
• Support regulatory activities associated with internal and external audits.
• Stay current on changes in regulatory requirements and trends and communicate relevant developments to key stakeholders.
• Provide regulatory guidance and support to cross-functional teams on post-market activities.
• Develop and deliver training programs on regulatory compliance topics for internal teams.

Qualifications:

Required qualifications:

• Bachelor's degree in a scientific or technical discipline.
• Minimum of 5 years' experience in Regulatory Affairs and/or Quality within the medical device industry, including a minimum of 3 years' experience in Regulatory Affairs.
• In-depth knowledge of U.S. regulatory requirements and working knowledge of international regulatory requirements, including the European Union Medical Device Regulation (EU MDR) and other global regulations.
• Proven experience managing PIRs, CAPAs, recalls and audits.
• Proficiency with Microsoft Office and Adobe Acrobat, with the ability to work effectively with databases, document control systems and quality management software.

Preferred qualifications:

• Advanced degree in a scientific or technical discipline.
• Strong analytical and problem-solving skills.
• Strong written and verbal communication skills, including technical writing and editing.
• Excellent interpersonal skills and demonstrated ability to collaborate effectively across teams.
• Ability to work independently and as part of a team.
• Ability to adapt to changing priorities and thrive in a fast-paced environment while meeting time-sensitive deadlines.
• Detail-oriented approach with strong organizational and project management skills.
• Demonstrated ability to use artificial intelligence tools to enhance efficiency, accuracy and decision-making, including regulatory research, document generation, data organization or workflow optimization, and a willingness to integrate AI into everyday work processes.

Requisition ID:633306

Minimum Salary: $102100

Maximum Salary: $194000

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.

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 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

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.

Nearest Major Market:

Minneapolis

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