J&J Family of Companies Global Regulatory Affairs, Diagnostics and Digital Health, Associate Director in Raritan, New Jersey
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Regulatory Affairs, Diagnostics and Digital Health, Associate Director. The position can be remote and preferably close to a Janssen location.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie%20yacco/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Janssen provides an opportunity to work in a highly innovative, new and growing precision medicine business in the Johnson & Johnson Pharmaceutical Sector. This senior level position reports in the Janssen Global Regulatory Affairs organization. The function supports regulatory affairs for companion diagnostics, in vitro diagnostics (IVD), mobile apps, and medical devices to Janssen drugs. Responsibilities include:
Support the Therapeutic Regulatory Leader, Global Regulatory Leader and/or Application Owner for regulatory activities for IVDs, Software as a Medical Device(SaMD) or Devices in development and/or marketed pharmaceutical products. Provide guidance and support to project teams regarding regulatory compliance issues.
Good understanding of the drug and device development process
Prepare, review, and implement regulatory strategies and plans for diagnostic or digital products identified and related to Therapeutic Areas
Handles timely coordination, compilation, and submission of new medical devices (especially IVDs) to the regulatory agencies with an emphasis on North America and European Union
Connect with notified bodies and regulatory authorities in order to expedite approval of regulatory submissions.
Perform copy review of press releases or scientific material to verify compliance with the approved claims.
Evaluate impact of product changes, historical regulatory strategy assessments, and maintaining product history files
Bridge the requirements between Drug and IVD/digital regulatory affairs and development teams
Maintain external contacts and help negotiations with US and international health authorities.
Provide mentorship, support, and prepare product development teams on regulatory issues.
Identify needed education, set up training sessions, and provide information on applicable topics
Monitors and trends the global environment for laws, directives, and regulations related to IVD and digital.
Bachelors degree in biochemistry, microbiology, pharmacy or life-science or health-related field with minimum 10 years business experience OR Masters degree in biochemistry, microbiology, pharmacy or life-science or health-related field with minimum 5 years business experience OR PhD in biochemistry, microbiology, pharmacy or life-science or health-related field with minimum 3 years business experience is required
Minimum 3 years relevant regulatory experience on US submissions (510k, PMA) and EU CE marking preferably for molecular diagnostic assays, and/or digital Medical Devices is required
Track record of successfully working within a cross-functional team environment as a contributor, decision maker, and creator of innovation
Proficient working understanding of software as a medical device and molecular techniques is preferred
Knowledge of the drug development process and Pharmaceutical regulations is preferred
Experience critically reviewing and highlighting major concerns is preferred
RAC Certification is preferred
This position can be full-time remote or preferred by a Janssen facility in European Union (preferably near Beerse Belgium), North America (preferably near NJ Raritan or PA Springhouse) with a willingness and ability to be either commute to Janssen locations or Heath Authority meetings as needed for projects is required. Travel could be 10-25% dependent upon personnel location.
Remote work options may be considered on a case-by-case basis and if approved by the Company
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-Canada-Ontario-Toronto, North America, Europe/Middle East/Africa, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-District of Columbia-Washington, North America-United States-New York, North America-United States-California-San Francisco, United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)
J&J Family of Companies
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