(Sr.) Regulatory Affairs Manager (Bilingual Mandarin)

Job Description

Job Description

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 oversightof 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, FDA and MDR / IVDR compliant Quality Management System.

Lead the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities. Responsible for US pre- market submissions and approvals / clearance such as 510(k), Q-subs, and EUA / Pre-EUA applications.

Responsible for 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.

Provide regulatory guidance and support to cross-functional product development and project teams throughout the product lifecycle.

Support regulatory activities required for MDR and IVDR compliance.

Provide regulatory impact assessment for changes to medical devices (e.g., manufacturing and design changes).

Provide regulatory review and approval of change order packets.

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.

Establish and manage the RA team in U.S.

Qualifications :

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 the US, EU, and China.

Demonstrated ability to communicate and negotiate with regulators for the least burdensome approaches to pre-market approval / clearance.

Demonstrated ability to manage 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 Devices and IVD submissions (Q-sub, 510(k), etc.). 510(k) experience with Software (SAME) and blood glucose monitoring systems preferred.

Minimum 2 years of managerial experience in the medical device industry

Benefits :

Medical, Dental, Vision, Life Insurance, and 401K

Paid Time Off, Federal Holidays, and Leaves

Annual Performance-Based Bonus

Salary : $80,000 - $140,000