Senior Regulatory Affairs Specialist

Boston Scientific is looking for a Senior Regulatory Affairs Specialist to support our rapidly growing active implantable device portfolio. The role requires strong US, EU, and international regulatory experience to help support international expansion. As part of a high-functioning Regulatory Affairs team, you'll be responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance, developing regulatory strategies, and partnering with global R&D, manufacturing, clinical, and quality teams.

Requirements

• A minimum of a Bachelor’s Degree in a scientific, technical, or related discipline
• A minimum of 4 years Regulatory Affairs experience in the medical industry
• Prior experience with 510(k) submissions, EU MDR or international regulatory registrations
• Prior experience with PMA submissions or Class III submissions
• Prior experience with active implantable devices, active devices, or long-term implants

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• Retirement plan
• Life insurance
• Paid time off
• 401(k) matching
• Holiday pay