Senior Regulatory Affairs Specialist

Boston Scientific • Maple Grove, MN

9d • $89,200 - $169,500 • Hybrid

About The Position

Boston Scientific is hiring a Senior Regulatory Affairs Specialist to support its growing active implantable device portfolio in the Urology division. The role provides Regulatory Affairs support for submissions and ongoing regulatory compliance throughout product development, and contributes to the development of regulatory strategies. The specialist will use U.S., EU, and international regulatory experience to help support international expansion, partnering closely with global R&D, manufacturing, clinical, and quality teams.

This is a hybrid role based in Irvine, California; Marlborough, Massachusetts; Arden Hills, Minnesota; or Maple Grove, Minnesota. Employees are required to work in a local office at least three days per week. Boston Scientific will not offer or assume sponsorship of an employment visa for this position at this time.

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 product development processes, design controls, 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 assess regulatory impact of product and manufacturing changes for compliance and effects on regulatory filings; support related global submissions as needed.
• Support coordination, drafting, and submission of 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 colleagues on projects, including support for international regulatory filings.
• Support highly technical or major business-segment product lines, special projects, or strategic initiatives.

What This Job Offers

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