Medical Device Compliance Manager

3 weeks ago


Baldwin Park, California, United States Ihealth Labs Inc Full time
About the Role

iHealth Labs Inc is seeking a Medical Device Compliance Manager to join our regulatory team.

The successful candidate will have a strong background in medical device regulations and a proven track record of ensuring compliance with regulatory requirements.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with ISO 13485, FDA, and MDR/IVDR regulations.
  • Lead the preparation and review of regulatory submissions, including 510(k), Q-sub, and EUA/Pre-EUA applications.
  • Collaborate with cross-functional teams to perform regulatory pre- and post-market analysis and implement Quality Management Systems.

Estimated Salary Range: $80,000 - $140,000 per year.

Location: Sunnyvale, California.

About iHealth Labs Inc: Founded in 2010, iHealth Labs Inc is dedicated to empowering people to live healthier lives through cloud-connected medical devices, personal health care devices, and home-based tests.



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