Janssen Research & Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Global Regulatory Affairs, Diagnostics. The position will be based in Raritan, NJ, Titusville, NJ, Rockville, MD, Boston, MA, San Francisco, CA, Fremont, CA, San Diego, CA, and Toronto, Canada.
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 Director, Global Regulatory Affairs, Diagnostics will:
• Manage the coordination, compilation and worldwide submission of (new) Medical Devices (MD) and In-Vitro Diagnostics (IVD) to the regulatory agencies.
• Specifically for Companion Diagnostics, bridges requirements between Drug and IVD regulatory affairs and development teams.
• Supports licensing of products developed by Janssen Diagnostics.
• Responsible for managing several multidisciplinary teams of professionals located mainly in 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, and others) to obtain timely registration of the diagnostic products.
• Make an impact assessment on company objectives. Inform management and relevant personnel as soon as possible about impact (generally through e-mail).
• Provides guidance and support to product development teams on regulatory issues.
• Upload new or changed regulations, standards and guidelines in shared access locations such as SharePoint.
• Provide input on regulatory changes for the Quality System management review meetings.
• Establish standard operational procedures to achieve efficiency within regulatory affairs.
• Minimum is a Bachelor’s Degree is required; an advanced degree (MS, PhD, MBA, MD, PharmD, etc) is preferred.
• Minimum 10 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 (IVD) is required.
• Experience with Companion Diagnostics is required.
• General knowledge of regulations for Drugs is required.
• Familiarity with GCP 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 RAPS certification is preferred.
• This position is located in Raritan, NJ, Titusville, NJ, Rockville, MD, Boston, MA, San Francisco, CA, Fremont, CA, San Diego, CA, and Toronto, Canada, and may require up to 25% travel, domestic and international.
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North America-Canada-Ontario-Toronto, North America-United States-California-San Francisco, North America-United States-New Jersey-Raritan, North America-United States-Maryland-Rockville, North America-United States-Massachusetts-Boston, North America-United States-New Jersey-Titusville, North America-United States-California-San Diego
Janssen Research & Development, LLC. (6084)
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