Regulatory Affairs Manager

24 Apr, 2022


Regulatory Affairs Manager

Innova Medical Group
Carlsbad, CA

The Regulatory Affairs Manager maintains the official record for all global product registrations, including JAPAC, EMEA and Americas and related to the design, manufacture, and sale of medical device and in-vitro diagnostic products. You will update the technical files with design changes and ensure, that additional submissions are completed. You will support the Regulatory Associates in maintaining regulatory approvals in keeping with our goals. You will report to the Senior Director of Regulatory Affairs.

You Will:

  • Maintain all necessary regulatory registrations, approvals and certifications to facilitate the sale of products in each regulatory market, including JAPAC (or EMEA or Americas)
  • Manage all Technical file documentation used for product submission
  • Incorporate product changes into product technical files
  • Verify and determine if product/technical file require additional submissions
  • Participate in product development activities ensuring local regulatory standards are understood and implemented to support regulatory submissions.
  • Obtain and maintain all necessary regulatory registrations, approvals and certifications to facilitate product sales in targeted markets

You Have:

  • Bachelor’s degree in Engineering, Biological Science, or related technical discipline, required
  • 5+ years’ experience in Regulatory Affairs for an in-vitro diagnostic company
  • Regulatory background with local market experience with Medical and In-vitro Diagnostic devices in in Asia Pacific countries including Japan, China, Singapore, etc.
  • Must have knowledge of and experience with local and global registration and submission requirements
  • Excellent management skills, both of individuals and projects
  • Conflict resolution
  • Work with different departments within the company
  • Project management. Monitor, detect and improve regulatory and compliance programs
  • Knowledge of IVD products
  • Experience with both IVDD and IVDR

Our Benefits

We offer competitive benefit plans and programs, including:

  • Medical, dental and vision insurance
  • 401(k) and 401(k) matching
  • Paid time off and sick leave

Employee Perks

  • Free daily lunches (Vegan & Vegetarian options included)
  • Stocked break-room, includes snacks and beverages
  • Gym located in office building for small access fee
  • Free parking
  • Referral program incentives

About the Company:

At Innova Medical Group, we believe better healthcare outcomes around the globe are within reach – and it starts with scalable and cost-effective screening and diagnostic options. As a leader in the research and development of in-vitro diagnostic reagents and test kits, Innova helps improve lives with testing, monitoring, and implementing medical care.

The global pandemic opened up a new era of virtual care and illustrated the need for better testing solutions beyond COVID-19. In response to the pandemic, Innova developed an end-to-end ecosystem of rapid diagnostic and screening tests, along with digital reporting and tracing applications to help organizations and governments manage the COVID-19 crisis. In 2020, we delivered more than 220+ million COVID-19 test kits to over 20 countries around the globe, including the United Kingdom, Hungary, Singapore, United Arab Emirates, and Myanmar.

We quickly became the world’s largest provider of COVID-19 tests, and we are determined to execute on this model across infectious disease, other chronic conditions and wellness, thereby empowering the global population to take control of their own care procurement and health decisions.

Our goal is to play an important role in care pathways by vitally contributing to improving patient outcomes and ultimately cutting overall treatment costs and bettering lives.

Innova Medical Group is a wholly owned subsidiary of Pasaca Capital, Inc. and is headquartered in Pasadena, CA.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Learn more here

Job posted: 2022-04-24