International Regulatory Affairs Professional

6 days ago


Minneapolis, Minnesota, United States Inspire Medical Systems I Full time
Job Overview

Inspire Medical Systems I is revolutionizing the sleep industry with its FDA-approved medical device designed to reduce Obstructive Sleep Apnea (OSA) severity for those who cannot tolerate or get consistent benefit from CPAP.

We are committed to enhancing patients' lives through sleep innovation, prioritizing patient outcomes, acting with integrity, and leading with respect.

Why You'll Thrive at Inspire Medical Systems I

We value people – their diverse experiences, backgrounds, and thoughts. We elevate voices, encourage learning opportunities, and build a professional network that grows into community.

We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you're passionate about making a difference in people's lives and want to work with innovative technology, this might be the ideal opportunity for you.

Key Responsibilities
  • Provide regulatory support for implantable neurostimulation therapy for the treatment of obstructive sleep apnea.
  • Focus on submission preparation, manufacturing and design change assessments, and supporting vigilance activities for Asia Pacific geographies.
  • Collaborate with in-country partners to meet regulatory objectives.
Requirements
  • Bachelor's degree.
  • 1 year minimum medical device industry experience in regulatory or quality function.
  • Strong writing and communication skills.
What Sets Us Apart

We offer a highly competitive benefits package including:

  • 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.

All employees have the opportunity to participate in the ownership and success of Inspire Medical Systems I through equity awards and the Employee Stock Purchase Program.



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