Regulatory Affairs Specialist II
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
