Senior Regulatory Affairs Lead for Medical Devices

Boston Scientific; Maple Grove (MN); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific in Minnesota and Massachusetts offers a hybrid work model for a Senior Regulatory Affairs Specialist. You will develop regulatory strategies, prepare global submissions, and partner with cross-functional teams to ensure lifecycle compliance of implantable medical devices.

You will mentor team members, coordinate regulatory reviews, and drive continuous improvement of our regulatory processes across development and integration initiatives.

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• Minimum of 4 years' experience in Regulatory Affairs within medical devices.
• Experience with implantable or active implantable medical devices.
• Experience preparing regulatory submissions for medical devices.
• Knowledge of FDA, EU and international medical device regulations.

Responsibilities

• Provide regulatory guidance and training to team members and cross-functional partners.
• Act as company representative with device reviewers on pre-submission strategy and submissions.
• Develop and implement regulatory strategies for new or modified products.
• Lead regulatory aspects of product integration and manufacturing process development.
• Review design changes for regulatory compliance and approve documentation.
• Submit global regulatory applications and maintain regulatory records.
• Review labeling and advertising for regulatory compliance.
• Provide training on policies and procedures.
• Support technical product lines including sterilization and integrations.
• Collaborate with regulatory colleagues to align product integration efforts.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

Regulatory submissions

Regulatory training

Education

Bachelor's degree in a scientific or technical discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Boston Scientific in Minnesota and Massachusetts offers a hybrid work model for a Senior Regulatory Affairs Specialist. You will develop regulatory strategies, prepare global submissions, and partner with cross-functional teams to ensure lifecycle compliance of implantable medical devices.

You will mentor team members, coordinate regulatory reviews, and drive continuous improvement of our regulatory processes across development and integration initiatives.