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Associate Director for Post-Market Programs

Company: Kelly
Location: Silver Spring
Posted on: November 21, 2022

Job Description:

Our Client is seeking an Associate Director for Post-Market Programs. This is a fully benefitted, DIRECT HIRE ROLE.
KEY RESPONSIBILITIES: Reporting directly to the Principal Deputy Office Director, your functions and responsibilities include, but are not limited to: --- Provides executive leadership to advance our client's goal of identifying and acting on significant safety signals related to medical devices marketed in the U.S. and other major markets first or in coordination with regulatory agencies of other major markets
Job Description: Associate Director for Post-Market Programs --- Oversees the client's Signal Management Program which supports the evaluation of benefit/risk profiles of medical devices once in the marketplace and in use by clinical and patient communities) --- Serves as the expert authority and leader in oversight of post-market issues related to medical devices and in the development and implementation of significant policies for medical devices. --- Serves as an expert consultant in collaborating with subject matter experts for the planning, monitoring, and administration of programs and projects that encompass the most critical post-market work --- Provides oversight and guidance into the post-market and signal identification operations, addressing emerging issues that need to be resolved as well as planning for future operations. --- Oversees coordination of work among projects in support of a functional discipline. Creates and facilitates internal and/or cross-functional teams that collaborate to accomplish complex, challenging scientific and/or operational objectives. --- Prepares or delivers briefings, papers, post-market documents and/or presentations. This includes but is not limited to: briefings to the Commissioner on how safety issues are being handled; briefings to congressional staff about safety issues; commenting on proposed legislation; preparing communications for technical and lay audiences. --- Oversees the development and implementation of regulations and guidance related to the post-market oversight of medical devices, including planning, and executing the Office's regulatory and guidance initiatives. --- Collaborates with multiple offices, domestically and internationally on post market planning and development of guidance.
CANDIDATE QUALIFICATIONS: Candidates must have professional experience and qualifications commensurate with the duties of the position. Qualified candidates should possess:
Education:At a minimum, the candidate must possess a degree in a scientific field, medical degree (with a current medical license) or a related degree from an accredited institution of higher learning.
Qualifications and Experience: --- At least five (5) years of relevant experience and expertise related to medical devices. This experience can be in either the corporate or federal public health sector --- Extensive experience with handling post-market issues --- Experience with products being recalled from the market--- Experience with safety issues in relation to medical products and reporting of safety issues --- Experience collaborating across cross functional departments, both on an international and national level --- Knowledge of clinical benefits and risks --- Experience developing communications in relation to medical devices --- Capable of identifying and analyzing a comprehensive rubric for benefit risks --- At least three (3) years of team management experience --- Experience identifying risks and parameters for program success

Keywords: Kelly, Silver Spring , Associate Director for Post-Market Programs, Executive , Silver Spring, Maryland

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