Senior Regulatory Affairs Specialist

Boston Scientific • Arden Hills, MN

12d • $89,200 - $169,500 • Hybrid

About The Position

Boston Scientific is hiring a Senior Regulatory Affairs Specialist in its Urology division to support a growing portfolio of active implantable devices. This hybrid role supports regulatory submissions and ongoing regulatory compliance throughout the product development process, and develops regulatory strategies. The specialist will use US, EU, and international regulatory experience to support international expansion while partnering with global R&D, manufacturing, clinical, and quality teams. The role is based in one of the listed offices—Marlborough, Massachusetts; Irvine, California; Arden Hills, Minnesota; or Maple Grove, Minnesota—and requires working from the local office at least three days per week. Boston Scientific will not provide or assume employment visa sponsorship for this position.

Requirements

• Bachelor’s degree in a scientific, technical, or related discipline.
• At least 4 years of Regulatory Affairs experience in the medical industry.
• Prior experience with 510(k) submissions, EU MDR, or international regulatory registrations.

Nice To Haves

• Prior experience with PMA submissions or Class III submissions.
• Prior experience with active implantable devices, active devices, or long-term implants.
• Working knowledge of FDA, EU, and international medical-device regulations.
• General understanding of the product development process, design control, and quality system regulations.
• Ability to manage several projects simultaneously.
• Proficiency with Microsoft Office.
• Effective research and analytical skills.
• Effective written and oral communication, technical writing, and editing skills.
• Ability to work independently with minimal supervision.

Responsibilities

• Review change notifications and conduct regulatory impact assessments for product and manufacturing changes, including effects on compliance and regulatory filings; support related global submissions as needed.
• Coordinate, draft, and submit U.S. and EU regulatory filings for new and modified Class III products.
• Provide technical reviews of test protocols and reports.
• Assess labeling materials, including Instructions for Use.
• Represent Regulatory Affairs on cross-functional project teams.
• Liaise with international Boston Scientific Regulatory Affairs colleagues on projects, including supporting international regulatory filings.
• Support highly technical or major business-segment product lines, special projects, and strategic initiatives.

Benefits

• Core and optional employee benefits are offered; the posting refers candidates to www.bscbenefitsconnect.com for details.
• Exempt, non-sales roles may include an annual bonus target and long-term incentives, subject to plan eligibility and other requirements.

What This Job Offers

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