Senior Regulatory Affairs Specialist

Boston Scientific • Georgetown, MA

1d • $89,200 - $169,500 • Hybrid

About The Position

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. As a Senior Regulatory Affairs Specialist, you will provide Regulatory Affairs support for product development, sustaining engineering projects and acquisition integration activities. In this role, you will develop regulatory strategies, prepare global regulatory submissions and partner with cross-functional teams to help ensure products meet regulatory requirements throughout the product lifecycle. This is an exciting opportunity to contribute to innovative technologies while supporting strategic initiatives that help expand Boston Scientific's Urology portfolio.

Requirements

• 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.

Nice To Haves

• 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.

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.
• Provide training on departmental and divisional policies and procedures.
• 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.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior