Senior Specialist in Regulatory Affairs

1 week ago

Sunnyvale, California, United States Ihealth Labs Inc Full time
Position Overview

Location: Sunnyvale, California

Compensation: $80,000 - $140,000 based on relevant experience

Company Overview:

Established in 2010, iHealth Labs is committed to enhancing individual health outcomes. As a prominent provider of connected medical devices, personal health solutions, and home testing kits, we are leading the charge in the digital health landscape.

In 2018, we introduced our Unified Care initiative to tackle chronic disease management. Our specialists offer support to patients at home through remote monitoring and chronic care management, aiming for improved health results.

In November 2021, our COVID-19 Antigen Rapid Test gained Emergency Use Authorization from the U.S. FDA for over-the-counter distribution. Since then, we have emerged as a vital supplier of at-home COVID tests to various governmental and non-governmental entities.

iHealth Labs strives to transform the healthcare sector by making effective health management accessible and affordable for everyone.

Key Responsibilities:
  • Contribute to the regulatory team overseeing the development and market launch of medical devices.
  • Collaborate with Quality, Engineering, Product Management, Marketing, and Sales teams to conduct regulatory analyses and maintain an ISO 13485 and FDA compliant Quality Management System.
  • Assist in the preparation and evaluation of regulatory submissions to the U.S. FDA and international regulatory bodies.
  • Support interactions with government entities regarding medical device registrations and licensing.
  • Engage in the formulation of regional regulatory strategies and adapt them in response to regulatory updates.
  • Manage FDA 510(k) and EUA applications.
  • Provide regulatory guidance to cross-functional product development teams throughout the product lifecycle.
  • Ensure compliance with MDR requirements.
  • Evaluate manufacturing and design changes from a regulatory perspective.
  • Review and approve change order packets.
  • Conduct regulatory intelligence and risk assessments.
  • Assist in maintaining compliance with post-market product requirements.
  • Support post-market regulatory actions for products.
  • Review advertising and promotional materials for regulatory compliance.
  • Facilitate internal and external audits.
  • Ensure adherence to internal procedures and external regulations.
  • Update and maintain quality system documentation.
  • Oversee quality records and controlled documents.
  • Perform additional regulatory and quality-related tasks as assigned.
Qualifications:
  • Bachelor's degree in Science, Engineering, Mathematics, a medical field, or a related discipline with a focus on technical writing and scientific methodologies.
  • A minimum of 5 years of experience in medical device Regulatory Affairs, demonstrating a solid understanding of regulatory frameworks.
  • Proven ability to manage small projects with exceptional organizational skills and a focus on outcomes.
  • Excellent analytical and communication skills, complemented by a strong sense of teamwork and attention to detail.
  • Capability to independently handle 510(k) submissions.
  • Bilingual proficiency in Mandarin is highly preferred.
Benefits:
  • Comprehensive Medical, Dental, Vision, Life Insurance, and 401K plans.
  • Generous Paid Time Off, Federal Holidays, and Leave policies.
  • Annual Performance-Based Bonus.

Equal Opportunity Statement:

iHealth Labs is dedicated to fostering diversity within its workforce and is proud to be an equal opportunity employer. We consider 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.

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