Sr.) Regulatory Affairs Specialist

(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

• 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.

• 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.

• Medical, Dental, Vision, Life Insurance, and 401K
• Paid Time Off, Federal Holidays, and Leaves
• Annual Performance‑Based Bonus