Principal Regulatory Affairs Specialist

Additional Location(s):  N/A

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 this 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, radiofrequency ablation, and enteral feeding.

We continue to invest in innovation across both established platforms and new pipeline development. As a Principal 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.

 

Work Mode

At Boston Scientific, we value collaboration and synergy. This role follows hybrid work model, requiring employees to be in our local office three days per week.

Relocation

Relocation assistance is not available for this position at this time.

VISA

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

 

Your responsibilities will include: 

• Represents RA on cross functional projects which may include product development, manufacturing process changes, site transfers, and continuous improvement efforts 
• Develops domestic and international strategies for regulatory approval of new and modified medical devices.  This includes strategies for gaining CE Mark under EU MDR
• Authors, coordinates, compiles, and submits US regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports
•  Supports international regulatory partners with commercial marketing applications and post-market studies
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings 
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings 
• Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
• Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
• Develops and maintains positive relationships with regulatory agency staff 
  Lead and/or participate in regulatory audits, as required 
• 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

 

Required qualifications: 

• Bachelor's Degree, or the equivalent combination of education and experience required
• 7+ years of experience in Regulatory Affairs, or 5+ years of experience with an advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline
• Demonstrated leadership, strategic thinking, project planning, and project management skills 
• Demonstrated ability to assess the impact of global regulatory requirements on projects and determine strategy to ensure cost, schedule, and performance requirements are met on multiple projects 
• Demonstrated ability to apply regulatory knowledge across multiple projects and communicate long term implications of regulatory, clinical, marketing, and business strategies for global product commercialization 
• Ability to influence and negotiate product development strategies and product approvals with global regulatory bodies 
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