24 days old

Associate Director for Compliance and Quality - FDA - Silver Spring, MD

Kelly Services
Silver Spring, MD 20915
The _Center for Devices and Radiological Health_ ( _CDRH_ ) is a department of the _Food and Drug Administration_ ( _FDA_ ) responsible for protecting and promoting the public health. They assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. They provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products that are within their oversight. The CDRH facilitates 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 U.S.

The FDA, CDRH is seeking a seasoned and innovative leader to serve as **Associate Director for Compliance and Quality** . The Quality and Compliance Program is located within the _Office of Product Evaluation and Quality_ ( _OPEQ_ ), that is responsible for setting strategy and overseeing the Offices of Health Technology 1- 7, _Office of Clinical Evidence & Analysis_ ( _OCEA_ ), _Office of Regulatory Programs_ ( _ORP_ ), Quality & Analytics Staff, Clinical & Scientific Policy Staff, Strategic Initiatives Staff, Regulation Policy & Guidance Staff, Compliance and Quality Staff, and Operations Staff. Using a focused Total Product Lifecycle approach, the Office ensures quality end-to-end device evaluation, and the consistent interpretation and application of regulatory policy and guidance. OPEQ ensures that these activities are aligned to the overall strategy and priorities of CDRH and FDA and contains staff responsible for the scientific and clinical evaluation of medical technologies, Regulatory Compliance, Quality Management and Analysis, and Strategic Initiatives.

The Associate Director serves as the expert authority and leader in an area of regulatory specialization and develops broad and complex regulatory programs. As the top expert in this specialized area, the incumbent is a member of the OPEQ leadership team, and provides information and consultation to individuals, federal agencies, private industry, universities, and/or foreign governments on consumer safety issues.


Reporting directly to the OPEQ Director, Center for Devices and Radiological Health (CDRH), the Associate Director for Compliance and Quality will prioritize the following key duties and responsibilities:

+ Develops, interprets, and issues policy and guidance on the regulated activities of industry, other Federal agencies, and the general public.

+ Provides oversight, coordination, and guidance to Offices of Health Technology with regard to specific high-impact compliance actions that CDRH may take in order to protect and promote public health. This includes coordination of those actions across CDRH, FDA and other agencies as needed.

+ Provides strategic oversight, coordination, and guidance of CDRHs approach to high-profile compliance and quality issues that may impact multiple device manufacturers and/or span multiple device areas.

+ Oversees the development and implementation of a compliance and quality education program for staff and managers, including specialized training for certain individuals, so that CDRH can successfully integrate pre- and post-market information and take prompt and appropriate compliance actions as needed.

+ Serves as an expert consultant in working and collaborating with subject matter experts for planning, monitoring, and administration of programs and projects that encompass the most critical compliance and quality work in OPEQ and provides oversight and guidance into the OPEQ compliance and quality operations, addressing emerging issues that need to be resolved as well as plan for future operations.

+ Solves complex problems involving diverse aspects of great difficulty, where procedures require frequent modification and change to incorporate revised techniques for OPEQ. Prepares or deliver briefings, papers, compliance documents and/or presentations.

+ Oversees the development and implementation of regulations and guidance related to the compliance and quality oversight of medical devices, including planning and executing the Offices regulatory and guidance initiatives.

+ Serves as the senior medical device compliance and enforcement officer for OPEQ, directly impacting a staff of more than 1400.

+ Oversees the Case for Quality and Intelligent Manufacturing Programs and fosters the development of innovative approaches to enhancing device quality.

+ Oversees OPEQs implementation and transition to ISO 13485 from current quality system regulations.


As Associate Director, you will exercise all administrative, supervisory, and technical responsibilities for all the OPEQ Compliance and Quality programs. This includes managing a multi-disciplinary program providing leadership, direct management oversight to ten (10) or more subordinate support staff, and oversight of compliance, enforcement, and device quality activities for an Office of 1400 staff. The incumbent provides technical and administrative leadership and direction to the Office staff through subordinate supervisors and exercises the full range of first and second level supervisory responsibilities. The incumbent will evaluate the technical performance of the team and you will devote at least 25% of your time towards coaching, mentoring, and supervising the team.


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 Bachelors degree in Public Health, Health Care Quality, Health Care Compliance, Regulatory Compliance, or a related degree. Other degrees may be accepted for highly qualified candidates with relevant medical device, regulatory, or public health compliance and quality experience. Advanced degrees are desired.

**Qualifications and Experience** :

+ One (1) year of specialized experience at a level close to the of this job that has equipped you with the knowledge, skills and abilities required to successfully perform the duties of the position (GS 15 in the Federal Government or equivalent).

+ At least eight (8) years of quality and compliance medical product experience inside the federal government or in the private sector; exposure to public health initiatives is desired.

+ Demonstrated knowledge of the process and procedures employed in the design, production, packaging, quality control, use or marketing of medical devices and radiation emitting electronic products.

+ Demonstrated knowledge of the Federal Food, Drug, and Cosmetic Act and related regulations applicable to medical devices and radiation emitting products.

+ Executive level experience planning directing, and evaluating scientific, engineering, or medical programs and activities that demonstrates the ability to develop and implement organizational vision, mission, goals, and change, and to effectively manage a large complex organization or a multi-disciplinary scientific, technical, health related organization or academic institution. Experience on the executive team, or leadership of a quality management team within a medical device company exemplify desirable experience.

+ Prior leadership experience to include planning and assigning work to be accomplished by others; setting and adjusting short-term and long-term priorities; preparing schedules for completion of work with consideration of the difficulty and requirements of assignments, and the capabilities of employees; coaching and mentoring others.

+ 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 $200,000 or more, dependent on experience, education, and supporting licenses/credentials. A one time recruitment incentive (up to 25%), and an increased leave accrual rate may also be available to highly qualified candidates.

Duty location negotiable upon selection.

**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: 2022-09-12 Expires: 2022-10-13

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Associate Director for Compliance and Quality - FDA - Silver Spring, MD

Kelly Services
Silver Spring, MD 20915

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