April 26, 2021

Quality Assurance & Regulatory Affairs Specialist

Pasadena
Posted 5 months ago

Innova Medical Group, Inc. delivers better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world’s most challenging healthcare problems. Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious diseases.

In response to the global pandemic, Innova developed an end-to-end ecosystem of rapid diagnostic and screening tests, along with digital reporting and tracing applications to help organizations manage the COVID-19 crisis. In 2020, Innova 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.

As a leader in the research and development of in-vitro diagnostic reagents and test kits, Innova​ has improved lives with testing, monitoring, and implementing medical care. Innova Medical Group is a wholly owned subsidiary of Pasaca Capital, Inc. and is headquartered in Pasadena, CA.

Innova Medical Group is the world’s largest manufacturer of COVID rapid antigen test kits and other medical devices. We are going through an exciting phase of expansion and are looking for an experienced QA & RA Specialist to support regulatory submission activities such as compiling registration requirements to obtain and maintain marketing approvals for commercial distribution of products.

 

Responsibilities (Other duties may be assigned)

  • Log customer complaints and perform complaint investigations as needed – maintain CAPA files
  • Coordinate the review and investigation of returned products pertaining to customer complaints.
  • Assist with the management and submission of MDRS, recalls/FSNs and adverse event reports
  • Prepare quality trending reports for non-conforming product and customer complaints.
  • Coordinate and process nonconformance reports – e.g., log, investigate.
  • Fill out applications and forms for registrations and licensing.
  • Assist with the evaluation of suppliers and monitoring of performance.
  • Manage the external standards indexes.
  • Assist with internal and external audits and updating and/or modifying QMA SOPs.
  • Support labelling and ECR/ECO reviews
  • Support the implementing of ISO 13485 2016 and MDSAP as required
  • Maintain country license indexes and support data – e.g., MDSAP, EU, UK
  • Assist with regulatory device registration and renewals – FDA, Europe, UK, etc. inclusive of FDA device listings, Health Canada Fax-Back forms and Medical Device License Amendments, UDI registration – EUDAMED, GUDID, DORS, etc.
  • Assist with the maintenance and update of technical files.
  • Assist with external/quality audits by Customers and Regulatory Authorities.
  • Create product labels for manufacturing.
  • Assist with international requests for information for product registrations.

 

Requirements

  • Bachelor’s Degree, preferably in Engineering or Life Sciences or related field.
  • Experience with FDA QSR and ISO 13485 QMS requirements.
  • 3+ years’ experience in medical device regulatory compliance.

 

This job may be subject to a background check, consistent with State and local law, including where applicable the Los Angeles Fair Chance Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act.

Job Features

Job Category

Supply Chain

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