Regulatory Post-market And New Market Access Analyst

Inspire Medical Systems

Minneapolis, MN, United States
Base: $110,178 - $130,000 usd; bonus/equity: equit...
On-site
Us class iii device regulatory experience
Implantable device submission authoring
Eu and us regulatory gap assessments
Inspire Medical Systems is seeking a Regulatory Post-market and New Market Access Analyst to support their innovative medical device aimed at treating Obstructive Sleep Apnea. The role involves managing regulatory submissions, market access evaluations, and ensuring compliance in various international markets

Job Summary

  • The role provides critical regulatory support for neurostimulation therapy treating obstructive sleep apnea in adult and pediatric patients.
  • Candidates will evaluate market access requirements for new geographies including India, Brazil, and other regions in Asia and Latin America.
  • Inspire Medical Systems offers a competitive benefits package including health insurance, 401k matching, equity awards, and flexible time off.

Matching Summary

Match Score: 85

Inspire Medical Systems is seeking a Regulatory Post-market and New Market Access Analyst to support their innovative medical device aimed at treating Obstructive Sleep Apnea. The role involves managing regulatory submissions, market access evaluations, and ensuring compliance in various international markets.

Salary

Base: $110,178 - $130,000 USD; Bonus/Equity: Equity awards and ESPP available; Benefits: Multiple health plans, 401k match, tuition reimbursement

Skills & Requirements

Must-have

  • US Class III device regulatory experience
  • Implantable device submission authoring
  • EU and US regulatory gap assessments
  • Design history file document generation
  • Labeling and promotional compliance review

Nice-to-have

  • International market expansion in Asia and Latin America
  • Direct interaction with regulatory agencies
  • Engineering change order processing
  • New product development support

Key Requirements

  • Bachelor's degree in engineering, pharmacy, or scientific field
  • Five years of progressive Regulatory Affairs experience
  • Two years specific experience in Regulatory Affairs
  • Current authorization to work in the U.S. without sponsorship

Work Rights

Must have current authorization to be employed in the U.S. without employer sponsorship

Tailored Resume

Cover Letter