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
Education and Experience:
- Prefer Bachelor's Degree or equivalent combination of certification and proven work experience.
- 10+ years of progressive responsibility and experience in Quality Systems in Medical Device Manufacturing Environments
- Extensive experience in managing and developing people, projects and systems
- Must have demonstrated experience in preparation and submission of regulatory documentation including, but not limited to, 510(k), PMA, CLIA reclassifications, international registrations and technical files.
- Managerial Skills – Employee Development / Career Development / Financial Accounting/
- Communication Skills – Excellent Written and Oral Skills. Good listening skills.
- Excellent leadership and team building skills complemented by 'hands on" style or capabilities.
- This individual must possess a complete knowledge of Quality System requirements (ISO, CMDR, QSR, IVDD and other worldwide regulations as appropriate) a sense of the current and future regulatory climate and a pragmatic approach in developing, implementing and administrating the quality system within defined regulations while meeting corporate strategic objectives.
- This individual must be able to effectively manage multiple priorities in a fast paced and dynamic environment. This position requires the effective communication, persuasion and technical skills to develop, present and implement ideas to senior corporate management.
- The individual must be knowledgeable with respect to quality systems, regulatory standards, product development and project management.
- The Director, Regulatory Affairs will aid to determine the appropriate strategy and evolution of the corporate regulatory system. This individual is responsible for defining and directing decisions to support the quality policy. The Director is responsible for prioritizing initiatives and focusing resources to optimize the impact on the company's strategic imperatives.