(Sr.) Regulatory Affairs Specialist

Work Location: Sunnyvale, California

Salary Range: $80,000 - $140,000

Job Type: Full-Time Onsite

Our Company:

Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests and is at the forefront of the digital health revolution.

In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization from the U.S. Food and Drug Administration for over-the-counter sales. Since then, iHealth has become a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers.

iHealth Labs is a leader in digital health solutions, with a mission to revolutionize the healthcare industry by making quality health management accessible and affordable for all.

Job Responsibilities:

• In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.
• You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis, and implement, maintain, and comply with an ISO 13485 Quality Management System.
• Preparation of regulatory submissions to the US FDA and international (outside the US) regulatory authorities.
• Assistant RA manager with US pre-market submissions and approvals/clearance such as 510(k), Q-subs, and EUA/Pre-EUA applications.
• Assistant RA manager with government interactions pertaining to premarket submissions, postmarket reports, medical device registrations, establishment registrations, and listing requirements.
• Participate in the development of regional (OUS) regulatory strategy and update strategy based on regulatory changes.
• Assistant RA manager to provide regulatory guidance and support to cross-functional product development and project teams throughout the product lifecycle.
• Assistant RA manager to 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 the review of 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 educational background with a focus on technical writing, scientific methodologies, and problem-solving.
• A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a 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, displaying 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, enabling effective communication within a diverse team and potential global partners.
• 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