1+ months

Associate Director for Post-Market Programs - FDA - Silver Spring, MD

Kelly Services
Silver Spring, MD 20915
The _Food and Drug Administration_ ( _FDA_ ) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the _Center for Devices and Radiological Health_ ( _CDRH_ ) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States.

FDA/CDRH is seeking an **Associate Director for Post-Market Programs** to support the _Office of Product Evaluation and Quality_ ( _OPEQ_ ) within CDRH. OPEQ assures patients have access to high quality, safe and effective products throughout the total product lifecycle. Among its many roles, OPEQ implements program areas through which medical devices are evaluated or cleared for clinical investigation or marketing; evaluates, enhances, and ensures compliance with medical device laws; fosters a culture of quality within an ever-expanding global medical device market; and regulates radiation-emitting non-medical products.


Reporting directly to the Principal Deputy Office Director, OPEQ, your functions and responsibilities include, but are not limited to:

+ Provides executive leadership to advance FDAs 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

+ Manages four (4) direct reports in addition to overseeing work related to Post-Market Programs across all of OPEQ.

+ Oversees OPEQs 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 in OPEQ

+ Provides oversight and guidance into the OPEQ 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 Offices regulatory and guidance initiatives.

+ Serves as the senior advisor to the OPEQ Super Office Director and Deputy Super Office Director on post-market programs.

+ Collaborates with multiple offices, domestically and internationally on post market planning and development of guidance.

+ Helps shape the direction of FDAs Unique Device Identifier Program


Candidates must have professional experience and qualifications commensurate with the duties of the position. Qualified candidates should possess:


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

+ Must be a U.S. Citizen


An attractive compensation package will be offered based upon background and experience, and commensurate with the FDA guidelines, to include an anticipated annual salary in the range of $170,000 to $205,000 (Cures Band F), dependent on experience, education, and supporting licenses/credentials. MDs with active medical licenses may be eligible for higher salaries.

If selected, the candidate must submit financial disclosures in accordance with CDRH regulations.

**Duty location is the FDAs Silver Spring, MD campus, but may be negotiable upon selection subject to applicable agency policies and procedures.**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Government Solutions?**

Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government Solutions partners with these organizations to create expert talent solutions that solve the worlds most critical challenges. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles. Our experts will connect you to the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-08-19 Expires: 2022-10-20

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Associate Director for Post-Market Programs - FDA - Silver Spring, MD

Kelly Services
Silver Spring, MD 20915

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