Principal Regulatory Affairs Specialist
Company: DiaSorin Molecular
Position: Principal Regulatory Affairs Specialist
Location: Cypress, CA
Posted: August 17, 2021
For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.
DiaSorin Molecular, LLC is headquartered in Cypress, Ca. Our technology enables diagnosis of disease by detecting specific RNA and DNA sequences. We focus on design, development and cGMP Manufacturing.
We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.
We are looking for an advanced Regulatory Specialist that will provide pre-market regulatory strategy planning and implementation to ensure regulatory requirements are incorporated and approved for new and modified products. Utilize your expertise in European regulations, in-vitro diagnostics and trade compliance.
What will you do?
-Prepare regulatory assessments of product changes, documenting rationale, actions and following through with notifications internationally as needed.
-Create/ revise/ review and submit Annual Reports for US and Canada.
-Provide international STED submissions and requested declarations and other documentation to subsidiaries/distributors to obtain and maintain registrations.
-Participate in regulatory training and transfer the information back to the Regulatory department providing insightful application.
-Communicate regulatory information to assist with trade compliance, CDC, and import/export activities.
- Author 510(k) perform reviews for submissions at other DiaSorin sit
Bachelor’s Degree in life science or engineering.
-5 years minimum Regulatory medical device experience, at least several years in IVD, doing US, European, and or international submissions.
-Prior experience in interacting with FDA staff and/or other regulatory agencies and demonstrated success in securing regulatory approvals.
-Knowledge of US, European, international regulations and standards, and experience in preparing regulatory submissions
-Proven analytical capabilities, solid understanding of manufacturing and change control, and good manufacturing practices.
-Ability to speak effectively before groups of customers or employees of organization and ability to organize information to compose reports, documents and presentations.
-Knowledge/Understanding of USDA, CDC, import/export requirements for imported animal/human raw materials and finished goods
- Experience authoring procedures and determining applicable regulations/standards/guidance for products/processes.
- Experience in authoring of IVD 510(k), EU IVDR, and Canada licenses preferred.