The incumbent will serve as a Lead Consumer safety officer within the Division on an assigned team.
The incumbent serves as the technical scientific authority involving programmatic operations involving enforcement of the Medical Device Amendments of 1976 including the Safe Medical Device Act of 1990 and 1992, and Radiation Control for Health and Safety Act of 1968.
Keeps fully abreast of crucial and precedent setting cases under review within the team and division in the medical device product industry as well as related cases in the Office.
Identifies and assesses emerging, standing, complex issues impacting the Offices operational procedures and policies.
Ensure that the organizations strategic plan, mission, vision and values are communicated to the team and integrated into the teams strategies, goals, objectives, work plans and work products and services;
Lead the team in identifying, distributing and balancing workload and tasks among employees in accordance with the established work flow, skill level and/or occupational specialization; making adjustments to accomplish the workload in accordance with established priorites io ensure timely accomplishment of assigned team taska; and ensuring that each employee has an integral role in deveoping the final team product.
Conducts briefings and presentations to the team, Deputy and Division Director for which the senior Consumer Safety Officer is responsible. Frequently facilitates resolutions of difficult medical device compliance issues.
Participates in meetings on issues related to the programs, meets with representatives of regulated compliance firms and professional groups in the area. Maintains continual relationships with other organizations within the Center and the Agency and the medical device industry.
Prepares written analyses and evaluations. May serve as an expert witness in trials, and Congressional or court hearings.
Serves as a crucial developmental resource for lower level scientific employees and may provide training, assistance, and guidance to individuals in the area of compliance involving regulated medical devices.