Quidel Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well being of people around the globe with well known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, cardiology, women's health, and virology.
Quidel is searching for a Director, Regulatory Affairs to work at one of our Sorrento Valley locations in San Diego. This role will manage the San Diego Regulatory Affairs team to manage regulatory activities related to the approval of new IVDs and Medical Devices into the worldwide market. The Director will provide guidance to product development teams on regulatory issues for the planning and compilation of critical documentation relating to the development process for the suitability for submission. This role ensures Quality System compliance with QSR, ISO, CMDR, IVDD and other worldwide regulatory requirements as appropriate, and promotes awareness of applicable regulatory and customer requirements by ensuring that applicable requirements comprise an integral part of the new hire orientation process, as well as during the regular operations and management review meetings.
Interprets FDA IVD/medical device regulations and provides regulatory planning and guidance to project teams. Implements regulatory plans.
Secures regulatory documentation including device licenses, medical device listings, permits, import/export certificates
Review promotional literature, labeling, ECO's and validations
Secures USDA licenses for veterinary products, including facilities plan and outline of production. Key contact with county, state and federal regulatory agencies for facilities inspections, licensures and permits
Prepares data for 510(k)/PMA submission and secures clearance/approval
Administers the MDR and vigilance program
Maintain and secure CE product marking