The RA Program Manager will assist in managing the Company's Regulatory processes to support a global provider of in vitro diagnostic products.
Responsible for implementing and managing the regulatory strategies and programs and to ensure compliance with regulatory agency requirements for the eventual clinical clearance/approval of products world-wide.
The position works in a team environment, interacting with all related cross functional groups throughout the organization, including executive management, quality, manufacturing, research and development, business development, finance, legal and consultants.
The position will be responsible for planning and managing the many aspects of regulatory submission necessary to support clinical trials, product registration and post-marked surveillance worldwide.
The RA Program Manager is responsible for acting as the Company's advisor and interface for all regulatory issues with senior management, regulatory consultants, the FDA and all other regulatory agencies world-wide as needed.
The RA responsibilities include working with FDA, Regulatory Authorities in other countries, Notified Bodies, and other third party organizations. The RA Program Manager will be responsible for managing 501k and PMA submissions in the US, submission world-wide, clinical studies design, implementation and data analysis, monitoring and reporting on the Company's continued compliance with regulatory requirements.
Lower level details include:
Closely works with the quality teams, project teams, and manufacturing organizations to provide regulatory and quality guidance, support, and direction.
Coordinates clinical studies.
Manages data analysis for submissions.
Writes submissions and manages communications with agencies during the submission process as needed.
Provides strong leadership for all regulatory team members, fosters a collaborative team environment within the quality organization and the entire company.
BS or BA in health care or related field and program management certification/training or proven success
RA Program Manager will be a seasoned knowledgeable profressional with a minimum of 10 years of experience in regulatory sciences, including a minimum of 5 years of proven success in managing 501(k) and PMA submissions, Asian and worldwide submission, clinical studies management and general compliance in the Diagnostic industry. Solid experience in problem solving skills, analytical thinking, and organizational skills are of major importance.
343 Oyster Point Boulevard
South San Francisco, CA 94080