Regulatory Affairs Lead
6 days ago
iHealth Labs Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team in Sunnyvale, California. As a key member of our regulatory team, you will be responsible for overseeing medical device development and market introduction. The successful candidate will have a minimum of 5 years of experience in medical device regulatory affairs, with a strong understanding of regulatory frameworks in the US, EU, and China.
Key Responsibilities:
• Collaborate with cross-functional teams to perform regulatory pre- and post-market analysis
• 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
• 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 communicate effectively with regulators and stakeholders
Benefits:
iHealth Labs Inc. offers a competitive salary range of $120,000 - $200,000 per year, as well as comprehensive benefits including medical, dental, vision, life insurance, and 401K.
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