Medical Device Compliance Manager

4 days ago


Baldwin Park, California, United States Ihealth Labs Inc Full time
About the Role:
We are looking for an experienced Regulatory Affairs Manager to join our team at iHealth Labs Inc. in Sunnyvale, California. As a key member of our regulatory team, you will be responsible for ensuring that our medical devices comply with regulatory requirements in the US, EU, and China. The successful candidate will have a minimum of 5 years of experience in medical device regulatory affairs, with a strong understanding of regulatory frameworks and procedures.

Responsibilities:
• Develop and implement regulatory strategies to ensure compliance with ISO 13485, FDA, and MDR/IVDR requirements
• Prepare and review regulatory submissions to the US FDA and international authorities
• Collaborate with cross-functional teams to perform regulatory pre- and post-market analysis
• Provide regulatory guidance and support to product development teams throughout the product lifecycle

Requirements:
• Master's degree in Life Sciences, Engineering, Math, or a medical field
• Minimum 5 years of experience in medical device regulatory affairs
• Proven ability to analyze complex data and develop effective solutions

What We Offer:
iHealth Labs Inc. offers a competitive salary range of $100,000 - $180,000 per year, as well as comprehensive benefits including medical, dental, vision, life insurance, and 401K.

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