Senior Regulatory Affairs Specialist

About the role

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, our Urology business provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. These conditions account for more than 50% of all urology surgical procedures.

Responsibilities

• Provide technical guidance and regulatory training and mentoring to Regulatory Affairs team members and cross-functional partners.
• Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
• Develop and implement regulatory strategies for new and modified products.
• Act as the Regulatory Affairs lead on product integration workstreams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle while coordinating team inputs for regulatory submissions.
• Review and approve design and manufacturing changes, ensuring compliance with applicable regulations.
• Prepare and submit global regulatory applications, including U.S. and EU MDR submissions, maintain internal regulatory documentation and support international regulatory submissions.
• Review device labeling and advertising materials for compliance with global regulations, analyze findings and recommend appropriate changes.
• Support highly technical product lines, including product integrations, sterilization processes and other special projects or strategic initiatives.
• Participate actively in regulatory collaborations and alignment with other regulatory specialists supporting product integration efforts.
• Foster a work environment of continuous improvement that supports Boston Scientific's Quality Policy, Quality System and applicable regulations for the area of responsibility.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• Minimum of 4 years' experience in Regulatory Affairs or a related discipline within the medical device industry, including R&D, Quality, Clinical, Medical Affairs or Biocompatibility.
• Demonstrated experience with regulatory requirements for implantable or active implantable medical devices.
• Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices.
• Experience preparing regulatory submissions for medical devices.
• Demonstrated experience working within a product development process and design controls.
• Working knowledge of FDA, EU and/or international medical device regulations.

Preferred Qualifications

• Experience preparing a variety of regulatory submissions, including PMAs and 510(k)s for implantable or active implantable medical devices.
• Demonstrated knowledge of regulations applicable to the conduct of clinical trials.
• Demonstrated experience collaborating within a cross-functional team environment.
• Ability to manage multiple projects simultaneously.
• Strong research and analytical skills.
• Excellent written and verbal communication, technical writing and editing skills.
• Ability to work independently with minimal supervision.
• Strong interpersonal and influencing skills.
• Proficiency with Microsoft Word, Excel and PowerPoint.

Pay

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.

Schedule

This role follows a hybrid work model requiring employees to be in their local office at least three days per week. The position may be based in Maple Grove, Minnesota, or Marlborough, Massachusetts.