(Sr.) Regulatory Affairs Manager – Remote (USA)
Job Summary
iHealth Labs is hiring a (Sr.) Regulatory Affairs Manager to lead regulatory submissions and compliance for their medical device portfolio, including FDA 510(k), EUA, and MDR/IVDR processes. This fully remote role offers a competitive salary range of $80,000 to $140,000 per year and the opportunity to work with a leading digital health company revolutionizing at-home diagnostics and cloud-connected devices.
Key Responsibilities
Lead preparation and submission of FDA 510(k), Q-subs, EUA/Pre-EUA, and global regulatory documents.
Collaborate across Quality, Engineering, Product, and Marketing teams to ensure compliance with ISO 13485, FDA, and MDR/IVDR standards.
Manage regulatory interactions with FDA and global authorities.
Develop and update global regulatory strategy, including EU MDR and IVDR compliance.
Review and approve change orders, labeling, and promotional material.
Conduct regulatory assessments on product changes and risk analysis.
Represent Regulatory Affairs in internal/external audits and cross-functional reviews.
Establish and manage the U.S. Regulatory Affairs team.
Required Skills & Qualifications
Master’s degree in Life Sciences, Engineering, or related field.
Minimum 5 years’ experience in Regulatory Affairs for medical devices (US, EU, and China).
Proven success in preparing 510(k) submissions; Q-sub and IVD experience preferred.
Minimum 2 years of people management experience in the medical device sector.
Fluent in English and Mandarin.
Strong knowledge of regulatory frameworks: FDA, ISO 13485, MDR, IVDR.
Excellent organizational, communication, and problem-solving skills.
Ability to work independently and manage cross-functional projects.
Perks & Benefits
Competitive salary: $80,000 – $140,000 per year
Medical, Dental, Vision, Life Insurance, and 401(k)
Paid Time Off, Federal Holidays, Leaves
Annual performance-based bonus
Fully remote work flexibility
Company Description
iHealth Labs Inc., founded in 2010 and headquartered in Sunnyvale, California, is a leader in digital healthcare solutions. Known for their FDA-authorized COVID-19 at-home test kits and cloud-connected medical devices, iHealth is committed to making health management accessible and affordable globally.
Work Mode
Remote (USA-based applicants only)
Call-to-Action
Ready to advance your career in global medical device regulation? Apply now to join iHealth Labs and lead the future of digital health innovation.
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