iHealth Labs
(Sr.) Regulatory Affairs Specialist
iHealth Labs, Sunnyvale, California, United States, 94087
(Sr.) Regulatory Affairs Specialist at iHealth Labs
Location: Sunnyvale, California
Salary: $80,000 – $140,000 per year
Employment type: Full-Time Onsite
Seniority level: Mid-Senior
Job Responsibilities
Part of the regulatory team overseeing medical device development and market introduction.
Collaborate with Quality, Engineering, Product Management, Marketing, and Sales to perform regulatory pre- and post-market analysis and implement ISO 13485 Quality Management System.
Prepare regulatory submissions to the US FDA and international authorities.
Assist RA manager with US pre-market submissions and approvals/clearances such as 510(k), Q‑subs, and EUA/pre‑EUA applications.
Assist RA manager with government interactions for premarket submissions, postmarket reports, medical device registrations, establishment registrations, and listing requirements.
Participate in developing regional regulatory strategy and update based on regulatory changes.
Provide regulatory guidance and support to cross‑functional product development and project teams throughout the product lifecycle.
Provide regulatory impact assessment for changes to medical devices (e.g., manufacturing and design changes).
Support product regulatory intelligence and risk assessments.
Assist in maintaining compliance with product post‑market requirements.
Represent RA in reviewing advertising and promotional materials.
Support internal and external audits.
Ensure compliance with internal procedures and external regulations and standards.
Perform other regulatory duties as assigned.
Qualifications
Master’s degree in Life Sciences, Engineering, Math, a medical field, or an equivalent background with a focus on technical writing, scientific methodologies, and problem-solving.
Minimum of 5 years experience in medical device Regulatory Affairs, with comprehensive understanding of regulatory frameworks in US, EU, and China.
Demonstrated ability to communicate and negotiate with regulators for least burdensome approaches to pre‑market approval/clearance.
Demonstrated ability to participate in cross‑functional projects, with exceptional organization, independence, and outcome‑driven focus.
Outstanding analytical and written and verbal communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
Proactive approach and strong critical thinking skills.
Fluent in both English and Mandarin.
Experience authoring US Medical Device and IVD submissions (Q‑sub, 510(k), etc.). 510(k) experience with Software (SAME) and blood glucose monitoring system preferred.
Benefits
Medical, Dental, Vision, Life Insurance, and 401K
Paid Time Off, Federal Holidays, and Leaves
Annual Performance‑Based Bonus
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Salary: $80,000 – $140,000 per year
Employment type: Full-Time Onsite
Seniority level: Mid-Senior
Job Responsibilities
Part of the regulatory team overseeing medical device development and market introduction.
Collaborate with Quality, Engineering, Product Management, Marketing, and Sales to perform regulatory pre- and post-market analysis and implement ISO 13485 Quality Management System.
Prepare regulatory submissions to the US FDA and international authorities.
Assist RA manager with US pre-market submissions and approvals/clearances such as 510(k), Q‑subs, and EUA/pre‑EUA applications.
Assist RA manager with government interactions for premarket submissions, postmarket reports, medical device registrations, establishment registrations, and listing requirements.
Participate in developing regional regulatory strategy and update based on regulatory changes.
Provide regulatory guidance and support to cross‑functional product development and project teams throughout the product lifecycle.
Provide regulatory impact assessment for changes to medical devices (e.g., manufacturing and design changes).
Support product regulatory intelligence and risk assessments.
Assist in maintaining compliance with product post‑market requirements.
Represent RA in reviewing advertising and promotional materials.
Support internal and external audits.
Ensure compliance with internal procedures and external regulations and standards.
Perform other regulatory duties as assigned.
Qualifications
Master’s degree in Life Sciences, Engineering, Math, a medical field, or an equivalent background with a focus on technical writing, scientific methodologies, and problem-solving.
Minimum of 5 years experience in medical device Regulatory Affairs, with comprehensive understanding of regulatory frameworks in US, EU, and China.
Demonstrated ability to communicate and negotiate with regulators for least burdensome approaches to pre‑market approval/clearance.
Demonstrated ability to participate in cross‑functional projects, with exceptional organization, independence, and outcome‑driven focus.
Outstanding analytical and written and verbal communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
Proactive approach and strong critical thinking skills.
Fluent in both English and Mandarin.
Experience authoring US Medical Device and IVD submissions (Q‑sub, 510(k), etc.). 510(k) experience with Software (SAME) and blood glucose monitoring system preferred.
Benefits
Medical, Dental, Vision, Life Insurance, and 401K
Paid Time Off, Federal Holidays, and Leaves
Annual Performance‑Based Bonus
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