Senior Regulatory Affairs Strategist, Medical Devices

Boston Scientific Corporation; Maple Grove (MN); Hybrid; USD 107,000 - 203,000; Full time

Job summary

Boston Scientific Corporation seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for new and modified medical devices and to shape regulatory strategies across domestic and international markets. You will collaborate with cross-functional teams to ensure compliance and timely approvals, guiding labeling, changes, and audit readiness.

The role requires 5+ years in regulatory affairs, a Bachelor's degree, and proficiency with PMA/510(k) and EU MDR documentation.

Qualifications

• Bachelor's degree required.
• 5+ years in regulatory affairs or related device discipline.
• Experience authoring US/EU regulatory submissions (PMA, 510(k), EU MDR).
• Proficient in Word, Excel, PowerPoint and Adobe Acrobat for submissions.

Responsibilities

• Serve as company representative with regulatory reviewers.
• Coordinate and submit US/EU filings for new/modified devices.
• Develop regulatory strategies for Class II/III devices.
• Support training and cross-functional teams on regulatory requirements.
• Lead reviews of design/manufacturing changes for compliance.

Skills

Regulatory expertise

Cross-functional collaboration

Technical writing

Project management

Education

Bachelor's degree

Tools

Microsoft Word

Excel

PowerPoint

Adobe Acrobat

Job description

Boston Scientific Corporation seeks a Principal Regulatory Affairs Specialist to lead regulatory submissions for new and modified medical devices and to shape regulatory strategies across domestic and international markets. You will collaborate with cross-functional teams to ensure compliance and timely approvals, guiding labeling, changes, and audit readiness.

The role requires 5+ years in regulatory affairs, a Bachelor's degree, and proficiency with PMA/510(k) and EU MDR documentation.