J&J Family of Companies Global Regulatory Affairs (GRA) Diagnostics (Dx) Digital Director in Boston, Massachusetts
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 Director. The position can be remote and preferably close to a Janssen location.
Growing 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.
The Global Regulatory Affairs (GRA) Diagnostics (Dx) Digital Health Director manages the coordination, compilation and worldwide submission of (new) Medical Devices (MD), SaMD, and In-Vitro Diagnostics (IVD) to the regulatory agencies.
General Overview: Position is specifically targeting Digital and/or Dx devices associated with Janssen Therapeutics in development. Bridges 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:
Create and Execute on regulatory strategy for the company’s medical devices, especially use of Companion Dx, SaMD, Artificial Intelligence, Machine Learning, in-vitro diagnostic s(IVDs) and digital device expertise needed to support Janssen Therapeutic areas. Direct and lead preparation of the regulatory (submission) documents, e.g. 510(k)- & PMA-files IDEs, Pre-Submission packages, amendments, annual reports, etc either internal for Janssen or with a partner company.
For digital solutions, digital therapeutics, companion diagnostics(CDx) 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. Be the 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 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. Applying shown experience with IVD regulatory strategy for leading teams to innovative regulatory approvals.
Stayed on top of current and pending approvals in specific therapeutic/ digital devices, CDx/ 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 regulatory landscape on the company objectives and ability to communicate to senior management teams.
To be successful in the role, you will have the following experience and skills:
A Bachelor's degree and at least 10 years of health regulated industry experience is required
An advanced degree is preferred
An understanding of the drug product lifecycle from discovery to clinical trials to marketing is preferred.
Knowledge of Health Authority (HA) organizational structure and HA processes for reviewing submissions is required
Thorough knowledge of global regulations and device requirements for IVDs and SaMD required.
Knowledge of EU CE Mark, IVDR, MDR, GCP, QSR, CLIA, and FDA guidance documents is highly preferred.
Direct experience in development of regulatory strategies, creation of regulatory submission files and obtaining FDA clearance/approvals for any one of the following (Medical Devices, Digital therapeutics, SaMD, or In Vitro Diagnostics) is required.
Previous experience directly leading others is preferred.
RAC certification is preferred
A shown ability to effectively prioritize assignments for multiple products and projects simultaneously is required.
This position can be remote or preferred by a Janssen facility with a willingness and ability to be either commute to Janssen locations or Heath Authority meetings as needed for projects 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
United States-New Jersey-Raritan-920 US Highway 202
North America-United States-California-San Francisco, North America-United States-Massachusetts-Boston, North America-United States-Maryland-Rockville, North America-United States-Florida-Jacksonville, North America-United States-District of Columbia-Washington, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham
Janssen Research & Development, LLC (6084)
J&J Family of Companies
- J&J Family of Companies Jobs