Janssen Research & Development, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Global Regulatory Affairs, Diagnostics. The position will be based in Raritan, NJ or Titusville, NJ.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
The Associate Director, Global Regulatory Affairs, Diagnostics will:
• Manages the coordination, compilation and worldwide submission of (new) Medical Devices (MD) and In-Vitro Diagnostics (IVD) to the regulatory agencies.
• Assesses the regulatory requirements and activities for changes to existing cleared Medical Devices.
• Specifically for Companion Diagnostics, bridges requirements between Drug and IVD regulatory affairs and development teams.
• Contributes to the development and realization of business, e.g. by development of adequate regulatory strategies.
• This function supports the US Clinical Laboratory accreditation, licenses & permits for the CLIA laboratory in Huntington Valley, PA, and worldwide licensing of particular IVDs developed for Janssen Diagnostics.
• Responsible for managing several multidisciplinary teams of professionals located mainly in Europe and US.
• Develop the global regulatory strategy for the company’s medical devices and in-vitro diagnostic devices.
• Prepare or coordinate the preparation of submission documents.
• Maintain appropriate external contacts and negotiate with international health authorities (US, EU, a.o.) to obtain timely registration of the diagnostic products.
• Make an impact assessment on company objectives.
• Provides guidance and support to product development teams on regulatory issues.
• Provide input on regulatory changes for the Quality System management review meetings.
• Establish standard operational procedures to achieve efficiency within regulatory affairs, including the interfacing with other departments across MD&D, IVD and Drug development.
• Identify educational needs, set up training sessions, and provide information on applicable regulatory topics to involved personnel across applicable legal entities.
• Provide input to the management team in establishing short and long term business strategic plans and objectives. Direct implementation of business strategic plans in order to achieve objectives.
• Minimum is a Bachelor’s Degree is required; an advanced degree is preferred (MS, PhD, MBA, PharmD, etc)
• Minimum 8 years of overall experience is required. A minimum of 3-5 years of regulatory experience is required.
• Knowledge of global regulations for Medical Devices or In Vitro Diagnostics is required.
• General knowledge of regulations for Drugs is required.
• Familiarity with GCP, GMP, and clinical laboratory regulations and licensing is preferred.
• Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics is required
• RAC or RAPSC certification is preferred.
• This position is located in Raritan, NJ or Titusville, NJ and may require up to 20% travel.
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J2W: LI NA
United States-New Jersey-Raritan
North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
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