International Regulatory Affairs Specialist

Inspire Medical Systems - Golden Valley, MN

Full-time - Entry Level

Hybrid - Golden Valley, MN

Miscellaneous Manufacturing

About the position

The International Regulatory Affairs Specialist provides regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea. This role will focus on submission preparation, manufacturing and design change assessments, and supporting vigilance activities for Asia Pacific geographies. This role will collaborate with in-country partners to meet regulatory objectives.

Responsibilities

• Prepare documentation to support submission of new products and product changes.
• Coordinate regulatory assessment of product design and manufacturing changes.
• Work with technical experts in product development, quality, and clinical to address regulatory agency questions.
• Document field reports and complaints for regulatory reporting.
• Interact with international regulatory partners in local offices to support submission contents, as well as foreign regulatory agency reviewers to answer questions.
• Review labeling and promotional material for regulatory compliance.

Requirements

• Bachelor's degree
• 1 year minimum medical device industry experience in regulatory or quality function.
• Strong writing and communication skills.

Nice-to-haves

• Familiarity with EU, and/or other international medical regulations, device testing, and quality standards.
• Support for international regulatory agency submissions.
• International work experience or study abroad educational background.
• Complaint handling and/or post-market change assessment experience.

Benefits

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• Opportunity to participate in the ownership and success of Inspire through equity awards and the Employee Stock Purchase Program.