Sr. Regulatory Affairs Specialist

2 months ago

Sunnyvale, United States Ihealth Labs Inc Full time
Job DescriptionJob DescriptionWork Location: Sunnyvale, California

Salary Range: $80,000 - $140,000 depending on related working experience

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 2018, iHealth launched its Unified Care program to address the issue of managing chronic diseases. Unified Care specialists support patients at home between doctor’s appointments with remote patient monitoring (RPM) and chronic care management (CCM) to achieve better health outcomes.

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 and maintain an ISO 13485 and FDA compliant Quality Management System.

  • Participate in the preparation and review of regulatory submissions to the US FDA and international (outside the US) regulatory authorities.

  • Support government interactions pertaining to medical device registrations and licensing;

  • Participate in the development of regional regulatory strategy and update strategy based on regulatory changes.

  • FDA 510k and EUA application

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

  • Support regulatory activities required for MDR compliance.

  • Provide regulatory assessment for 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.

  • Support post-market regulatory actions taken for the products.

  • Assist in the review of advertising and promotional materials.

  • Support internal and external audits;

  • Ensure compliance with internal procedures and external regulations and standards.

  • Maintain and update quality system procedures.

  • Maintain quality records and other controlled documents.

  • Other Regulatory and Quality duties as assigned.

Qualifications:

  • Bachelor’s degree in Science, 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.

  • Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus.

  • Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail.

  • Can be independently responsible for 510(k) submissions

  • Bilingual in Mandarin is highly preferred.

Benefits:

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

  • Paid Time Off, Federal Holidays, and Leaves

  • Annual Performance-Based Bonus


Equal Opportunity Statement

iHealth Labs is committed to diversity in its workforce and is proud to be an equal opportunity employer. iHealth Labs considers qualified applicants without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, marital status, pregnancy, sex, gender expression or identity, sexual orientation, citizenship, or any other legally protected class. iHealthLabs is an Affirmative Action and Equal Opportunity Employer.

Please reference below for more information: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf and https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

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