Regulatory Affairs Specialist II

Boston Scientific; Marlboro (MA); Hybrid; USD 75,000 - 143,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Boston Scientific is seeking a Regulatory Affairs professional to support submissions and regulatory compliance across the development lifecycle. You will mentor teams, develop regulatory strategies for medical devices and coordinate with OEM/contract manufacturers to ensure registrations in the U.S., EU, China and beyond.

The role requires collaboration across manufacturing and development, preparation of global applications, and continuous quality improvements in line with our Quality Policy.

Qualifications

• Bachelor's degree in a scientific, technical or related discipline.
• Minimum of 2 years' Regulatory Affairs experience in the medical device industry.
• Experience with 510(k) submissions, EU MDR and international regulatory registrations.
• Working knowledge of FDA, EU and international regulations for medical devices.
• Ability to read and interpret global regulations and standards.
• General understanding of the product development process, design controls and quality system regulations.
• General understanding of regulations applicable to the conduct of clinical trials.

Responsibilities

• Provide technical guidance and regulatory training and mentoring to Regulatory Affairs employees and cross-functional teams.
• Assist with developing and implementing regulatory strategies for new and modified medical devices, as well as OEM and contract manufacturer partnerships.
• Serve as a liaison for new business partners, providing regulatory guidance for U.S., EU, China and international product registrations.
• Act as a core member of manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare and submit global regulatory applications and maintain internal regulatory file documentation.
• Review and approve product and manufacturing changes for compliance with applicable regulations.
• Support and maintain quality initiatives in accordance with Boston Scientific's Quality Policy.
• Continuously assess opportunities to improve quality.
• Develop and implement departmental and divisional policies and procedures.
• Support highly technical or major business-segment product lines, special projects and strategic initiatives.
• Review device labeling and advertising materials for compliance with global regulations and analyze and recommend appropriate changes.

Skills

Regulatory affairs

FDA submissions

EU MDR

Cross-functional collaboration

Project management

MS Office

Clinical trials

Education

Bachelor's degree

Job description

Additional Location(s): US-MA-Marlborough

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

About the role:

At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work.

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.

In the Urology division, we continually advance the quality of patient care with innovative urology solutions. We have a robust product portfolio and pipeline and continue to invest in urology treatments.

This role is responsible for Regulatory Affairs support for submissions and ongoing regulatory compliance throughout the product development process. The role will also develop regulatory strategies and provide support for new business development efforts involving external manufacturers, including original equipment manufacturers (OEMs) and contract manufacturers.

The position requires strong U.S., EU, China and international regulatory experience that can be leveraged to support international expansion. The ideal candidate will demonstrate flexibility in their work schedule to accommodate business needs and collaboration across teams.

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

Your responsibilities will include:

• Provide technical guidance and regulatory training and mentoring to Regulatory Affairs employees and cross-functional teams.
• Assist with developing and implementing regulatory strategies for new and modified medical devices, as well as OEM and contract manufacturer partnerships.
• Serve as a liaison for new business partners, providing regulatory guidance for U.S., EU, China and international product registrations.
• Act as a core member of manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare and submit global regulatory applications and maintain internal regulatory file documentation.
• Review and approve product and manufacturing changes for compliance with applicable regulations.
• Support and maintain quality initiatives in accordance with Boston Scientific's Quality Policy.
• Continuously assess opportunities to improve quality.
• Develop and implement departmental and divisional policies and procedures.
• Support highly technical or major business-segment product lines, special projects and strategic initiatives.
• Review device labeling and advertising materials for compliance with global regulations and analyze and recommend appropriate changes.

Qualifications:

Required qualifications:

• Bachelor's degree in a scientific, technical or related discipline.
• Minimum of 2 years' Regulatory Affairs experience in the medical device industry.
• Experience with 510(k) submissions, EU MDR and international regulatory registrations.
• Working knowledge of FDA, EU and international regulations for medical devices.
• Ability to read and interpret global regulations and standards.
• General understanding of the product development process, design controls and quality system regulations.
• General understanding of regulations applicable to the conduct of clinical trials.

Preferred qualifications:

• Experience supporting both capital equipment or medical electrical equipment and single-use disposable medical devices.
• Experience supporting contract-manufactured and/or OEM products.
• Ability to manage multiple projects simultaneously.
• Proficiency with Microsoft Office.
• Effective research and analytical skills.
• Effective written and oral communication, technical writing and editing skills.
• Ability to work independently with minimal supervision.

Requisition ID: 633801

Minimum Salary: $75100

Maximum Salary: $142600

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 by providing a 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, neurological and 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.