Global Regulatory Affairs (GRA) Diagnostics (Dx) Digital Associate Director.
Janssen Research & Development, L.L.C., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Global Regulatory Affairs (GRA) Diagnostics (Dx) Digital Associate Director. The position will be based at any one of the following locations; Raritan, NJ, Titusville, NJ, Horsham PA, Springhouse, PA, Boston MA, Washington DC, Rockville MD, Jacksonville FL, or San Francisco Bay Area CA.Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), Oncology, Immunology, and Infectious Disease. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com (http://www.janssenpharmaceuticalsinc.com).
The Global Regulatory Affairs (GRA) Diagnostics (Dx) Digital Associate Director coordinates and executes worldwide submission of (new) Medical Devices (MD), SaMD, and In-Vitro Diagnostics (IVD) to the regulatory agencies.
General Overview: Position is specifically targeting Digital devices as Stand-alone software and/or software applications associated with Drug treatment. assists in bridging requirements between Drug and Medical Device regulatory affairs, external partners, and development teams.
Contributes to the development and realization of business, e.g. by development of adequate, successful, and innovative regulatory strategies.
This function supports licensing of products developed by Janssen.
SCOPE OF RESPONSIBILITIES:
Assists on execution of US regulatory strategy for the company’s medical devices, especially use of SaMD, Artificial Intelligence, Machine Learning, in-vitro diagnostic devices, for US, and digital expertise needed to support Janssen Therapeutic areas. Assist, manage, maintain, and prepare the regulatory (submission) documents, e.g. 510(k) & PMA files IDEs, Pre-Submission packages, amendments, annual reports, etc.
For digital solutions, digital therapeutics, companion diagnostics medical devices, provide regulatory support to the Therapeutic Global Regulatory Leader for devices in development and/or marketed products in the assigned portfolio within the therapeutic areas. Lead Regulatory person for partnering with medical device partner companies for successful regulatory approvals of medical devices (including medical mobile apps and digital devices) and companion / complementary diagnostics
Providing regulatory expertise and support for digital health focus areas: software lifecycle management processes, medical device software, mobile medical applications, interoperability, cybersecurity, wireless, cloud, machine learning/artificial intelligence, and big data and advanced analytics.
Monitor and organize current and pending approvals in specific therapeutic/ US digital devices, companion diagnostic/ medical device areas and be knowledgeable of laws, directives, guidance(s) and requirements related to those areas. Provide assessments of the impact of new and changing regulations on the company objectives to the project teams.
To be successful in the role, you will have the following experience and skills:
– A Bachelor’s degree and at least 10 years health regulated industry experience is required
– An advanced degree in Pharmaceuticals, Biomedical, Engineering, or Biological Sciences is preferred
– Regulatory knowledge of digital medical device requirements and registration is required
– Knowledge of US FDA In Vitro Diagnostics device regulations and guidance documents is highly preferred.
– Working knowledge of global regulations for Software as a Medical Device (SaMD) with emphasis on US FDA regulations and requirements, data structures and software, and component integration, and development /validation of digital technologies and assets (wearable devices. AI, mobile apps) is required
– Familiar with GCP, QSR, CLIA, and FDA digital guidance documents is highly preferred.
– Direct experience in creation of regulatory submission files, meeting preparations, and obtaining FDA clearance/approvals for any one of the following (Medical Devices, Digital therapeutics, SaMD, or In Vitro Diagnostics) is required.
– Working knowledge of Companion Diagnostics regulatory requirements and approvals is preferred.
– RAC certification is preferred
– A proven ability to effectively prioritize and execute on assignments for multiple products and projects simultaneously is required.
– The willingness and ability to be located in either Raritan, NJ, Titusville, NJ, Horsham PA, Springhouse, PA, Boston MA, Washington DC, Rockville MD, Jacksonville FL , or San Francisco Bay area is required
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Job posted: 2020-05-04