Regulatory Affairs Associate

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as QuidelOrtho, we are seeking a Regulatory Affairs Associate who will perform operative duties such as ensemble submission dossiers for renewals and modifications, filling of submission, follow up to submission in the MOH web page. This position also perform QA business unit support activities, like follow up to notifications, conciliation and closure of notifications, follow up or CAPAs.

Major Duties & Responsibilities

Prepare new and renewal submission dossier by coordinate technical and legal documentation.

Prepare technical modification dossiers, including the digital copy and legal documentation.

Coordinate the conciliation of notifications, quality notifications and closure of them.

Support complains and notification compilation for the Technovigillance reports.

Support to the importation process by communication changes, approvals, label changes.

Follow up of submission in COFEPRIS system.

Feed back / up date of regulatory data base.

Perform other work related duties as assigned.

Other Duties

Provide MDS to Sales Representatives for Customers.

Support tender bids by providing legal documentation or regulation support.

Provide site CoAs for customers that require it.

Support marketing representatives with any regulatory information they shall need.

Support warehouse quality assurance operation as needed.

The Individual

Major in Pharmacy, Chemistry or Biochemistry.

At least 3 year of experience in quality and / or regulatory affairs.

At least 3 years of experience in pharmaceutical or life science industry in manufacturing / quality and / or regulatory affairs.

Advance knowledge in MS Office.

Fluent in English.

Traveling 10%