Senior Regulatory Affairs Specialist

Boston Scientific • Irvine, MA

19h • Hybrid

About The Position

Boston Scientific is seeking a Senior Regulatory Affairs Specialist in the Urology division to support its active implantable device portfolio. The role provides regulatory affairs support for submissions and ongoing regulatory compliance throughout product development, and develops regulatory strategies. It calls for US, EU, and international regulatory experience to support international expansion.

The specialist will join a close-knit Regulatory Affairs team and partner with global R&D, manufacturing, clinical, and quality teams. This hybrid role requires working in a local office at least three days per week. Candidates may be based in Irvine, California; Marlborough, Massachusetts; Arden Hills, Minnesota; or Maple Grove, Minnesota. 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.
• Ability to simultaneously manage several projects.
• 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.

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.

Responsibilities

• Review change notifications and assess the regulatory impact of product and manufacturing changes, including compliance with applicable regulations and effects on 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 colleagues on projects, including supporting 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