The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The successful candidate will be responsible for providing legal advice and support to help ensure that Quest Diagnostics test offerings and facilities are compliant with the relevant laws, regulations and guidelines that are under the purview of the FDA and the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This includes our manufacturing, transplant lab and blood transfusion labs as well as our clinical laboratories and the inter-relations between the two sets of laws and regulations. It will entail counseling Quest scientists and medical personnel as to the requirements they must meet in the development and validation of laboratory tests under FDA and CLIA regulations.
Additionally, the position will require:
· Guiding the company’s Companion Diagnostics, Pharmacogenomics, personalized medicine and clinical research projects through development and FDA submissions
· Legal oversight of the Company’s marketing review process for compliance with FTC and FDA marketing regulations
· Provide guidance and counsel to our regulatory staff regarding FDA inspections and preparedness for such inspections at our manufacturing facilities and our transplantation laboratory in Chantilly, Virginia. Quest also offers employee wellness programs, drug abuse testing for employment and insurance risk testing under SAMSHA.
· Offer direction on how the Company can provide, distribute and/or manufacture collection devices/kits for use in laboratory testing is essential as well as knowledge of international medical device laws, such as Canada and the EU
· Evaluate adverse events and approve filling of Biological Product Deviation Reports if needed for Quest and its Joint Ventures
Knowledge of FDA Quality System regulations and how they will apply to laboratories under newer developing FDA programs is essential
Knowledge related to CLIA, ISO certifications, OSHA, Stark and anti-corruption laws, international medical device and laboratory related laws, import and export laws regarding medical devices (anything else) is helpful, but not required
Present knowledge of medical device and biologics law and regulations is essential to the job. Knowledge of pending legislation affecting the Company is required to assist in meeting new requirements, including site registration, QSR implementation, employee training and marketing compliance
Science background in biology, chemistry, pharmaceuticals or toxicology
FDA experience obtained from being an FDA employed attorney, from a law firm with FDA specialty or as a corporate FDA counsel with focus on medical devices or diagnostics
Ability to interact with Quest Scientific and Medical personnel
Ability to counsel Quest business personnel on FDA issues
Good communication and inter-personal skills to provide training programs for Quest personnel regarding FDA laws and regulations and compliance
Experience related to CLIA and OSHA
Experience with international medical device laws, ISO certifications and import/export laws
Knowledge of anti-corruption laws
A juris doctorate or equivalent from an accredited law school
Admission and being in good standing to a state bar within the USA
Employer will assist with relocation costs.
Internal Number: req41137
About Quest Diagnostics
Recognized by FORTUNE magazine as one of the “World’s Most Admired Companies,” Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that doctors and patients need to make better healthcare decisions. They are pioneers in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.
With corporate headquarters in Secaucus, NJ, Quest Diagnostics is a Fortune 500 company, traded on the New York Stock Exchange and included in the Dow Jones Sustainability World Index. With 2018 revenues of $7.53 Billion, and approximately 46,000 employees and 6,600 patient locations across the US, Quest Diagnostics serves half of the physicians and hospitals in the US with their large variety of products and services.
The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics also provides services to employers, life insurance companies, other commercial labs, clinics, health plans, government agencies, ...and organizations involved in clinical trials research.
Approximately 150 million times each year, patients and their physicians rely upon Quest Diagnostics results to make important healthcare decisions.
Quest Diagnostics Healthcare IT solutions connect over 165,000 physicians.
Approximately one third of U.S. physicians – and many of the country’s leading hospitals and health systems – relies on Quest Diagnostics healthcare information solutions to foster better patient care and improve their business performance.
• FORTUNE magazine's "World's Most Admired Companies" list for 4 consecutive years; one of only five companies to attain Most Admired status in the "Health Care, Pharmacy and Other Services" industry category.
• Fortune magazine’s Fortune 500 list
• Forbes Global 2000
• Forbes' America's Best Employers List for third consecutive year
• Barron’s 500
• Member of the Dow Jones® Sustainability World Index
• Consistently named one of the best places to work in U.S. business journal rankings
• Named a DiversityInc Noteworthy Company for the second consecutive year in 2018
• Listed on the Disability Equality Index® (DEI), a joint initiative of the American Association of People with Disabilities (AAPD) and the US Business Leadership Network (USBLN), recognizing companies for prioritizing the inclusion of people with disabilities
Diagnostic Testing Services
Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. Their services range from routine blood tests — such as total cholesterol, Pap testing and white blood cell count — to complex, gene-based and molecular testing. They perform medical tests that aid in the diagnosis or detection of diseases, measure the progress or recovery from a disease or confirm that an individual is free from disease. In addition, they have specialized expertise in cancer, cardiovascular diseases, infectious diseases, and neurology.
In the $60 Billion and growing US Diagnostic Testing Market, Quest Diagnostics is the leader. Quest Diagnostics’ reputation as a leading innovator, provider of high value, low cost solutions and its financial strength and flexibility make it well positioned to capitalize on the evolving healthcare landscape.
Quest Diagnostics’ long-term strategy is to become the undisputed world leader in diagnostic testing, information and services. To drive this profitable growth, Quest Diagnostics plans to leverage capabilities to create differentiation:
• Deliver Innovative Solutions
• Leverage their Unparalleled Access and Distribution Network
• Expand their relationships with large payors and health systems
• Deliver Superior Patient Experiences