Senior Regulatory Affairs Specialist - Endoscopy

Senior Regulatory Affairs Specialist - Endoscopy

Onsite Location(s):
Marlborough, MA, US, 01752

Additional Location(s): US-MA-Marlborough

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

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:

At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions. Within our Endoscopy division, we develop and deliver advanced technologies that diagnose and treat diseases of the digestive system, airway, and lungs. Our portfolio includes solutions in balloon dilation, stenting, ERCP/cholangioscopy, biliary, biopsy and polypectomy, hemostasis, endobariatrics, radio frequency ablation, and enteral feeding.

This role in Regulatory Affairs will be responsible for developing regulatory strategies and providing support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The ideal candidate brings experience across U.S., EU, China, and other international markets to support expansion efforts and ensure global compliance.

We continue to invest in innovation across both established platforms and new pipeline development. As a Senior Regulatory Affairs Specialist
, you will play a key role in supporting the global regulatory strategy for our Endoscopy product lines—from new product introductions to sustaining and post-market activities.

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.

Your responsibilities will include:

• Develop and implement regulatory strategies for new and modified medical devices
• Provide regulatory guidance for OEM and Contract Manufacturer partnerships
• Act as a liaison for new business partners on US, EU, China, and international product registration
• Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
• Draft and submit U.S. and EU regulatory filings for new and modified medical devices
• Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
• Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
• Support associated global submissions in accordance with applicable regulations
• Represent the company in communications with regulatory agencies regarding submission strategy, testing requirements, and follow-up during review
• Support and maintain Boston Scientific s Quality initiatives in accordance with our Quality Policy
• Continuously identify and support opportunities for quality improvement across the organization

Qualifications:

Required qualifications:

• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
• Minimum of 4 years  experience in Regulatory Affairs within the medical device industry
• Strong working knowledge of FDA, EU MDR, and international medical device regulations
• Prior experience with 510(k) submissions
• Prior experience with EU MDR
• Prior experience with China and international regulatory requirements
• General understanding of product development and design control processes
• Familiarity with regulations related to the conduct of clinical trials
• Fluent in Mandarin

Preferred qualifications:

• Experience preparing and submitting 510(k), PMA, IDE, EU MDR, or international registrations
• Proficiency with Microsoft Office tools
• Strong analytical, research, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing abilities
• Demonstrated ability to work independently with…