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(Sr.) Regulatory Affairs Manager

2-5 years
$80,000 – $140,000 per year
10 July 18, 2025
Job Description
Job Type: Full Time Education: Master’s degree Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

(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.