Regulatory Affairs Specialist II

Additional Location(s): US-MA-Marlborough

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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.

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.

• 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.

• 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.

• Experience supporting both capital equipment or medical electrical equipment and single-use disposable medical devices.
• Experience supporting…