Principal Regulatory Affairs Specialist - Global Regulatory - Supplier Quality

Boston Scientific - Arden Hills, MN

Full-time - Senior

Hybrid - Arden Hills, MN

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

The Principal Regulatory Affairs Specialist will serve as the primary Regulatory Affairs representative for projects related to Supplier Quality and Material Controls at Boston Scientific. This role involves collaborating with cross-functional teams to ensure compliance with regulatory standards, participating in quality system projects, and influencing best practices across divisions. The position is hybrid, requiring in-office presence at least three days a week, with flexibility in location between Arden Hills, MN, Marlborough, MA, or Galway, Ireland.

Responsibilities

• Act as the Regulatory Affairs Lead on Supplier Quality and Material Controls initiatives.
• Collaborate with cross-functional partners to deliver innovative compliance solutions.
• Identify process gaps and opportunities for efficiencies in supplier change projects.
• Participate in Quality System Community of Practice forums as a Regulatory Affairs representative.
• Influence global partners and leadership on regulatory concepts and best practices.
• Engage in advocacy streams to monitor regulation trends and benchmark against industry leaders.
• Author, revise, and edit standard operating procedures and work instructions.
• Coordinate regulatory strategy and execute deliverables for manufacturing process changes.
• Train and mentor staff in regulatory affairs practices.
• Participate in department systems development initiatives.

Requirements

• Minimum of a Bachelor's degree.
• At least 5 years of experience in Regulatory Affairs or related fields within the medical device, IVD, pharmaceutical, or healthcare industries.
• Experience with Supplier Engineering, Supplier Quality, or Material Controls.
• Working knowledge of FDA, EU, and international medical device regulations.
• Ability to read and interpret global regulations and standards.
• General understanding of product development processes, design controls, and quality system regulations.
• Proficiency in Microsoft Office applications (Teams, Word, Excel, PowerPoint).

Nice-to-haves

• Degree or work experience in a scientific or technical discipline.
• Experience managing complex matrixed organizational structures.
• Excellent written and oral communication, technical writing, and editing skills.
• Strong research and analytical skills.
• Experience with audits from regulatory bodies (e.g., MDSAP and ISO 13485).
• Ability to manage multiple projects simultaneously.
• High sense of urgency and commitment to execution.
• Proven leadership, collaboration, and influencing skills.

Benefits

• Competitive salary
• Hybrid work model
• Access to training and development resources
• Opportunities for career advancement
• Diversity and inclusion initiatives