Johnson & Johnson · 1 day ago
Associate Director, Global Regulatory Affairs Diagnostics
Raritan, NJ
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$137K/yr - $236K/yr
10+ years expJohnson & Johnson is a leader in healthcare innovation, committed to delivering breakthroughs in health for humanity. The Associate Director, Global Regulatory Affairs Diagnostics will oversee regulatory strategies for diagnostic products and ensure timely registration with health authorities, while collaborating with cross-functional teams to support therapeutic product development.
Hospital & Health Care
Responsibilities
Contribute to the development and realization of business objectives by preparing, reviewing, and implementing regulatory strategies for diagnostic products related to the therapeutic product development
Oversee the coordination and compilation of global submissions for (new) In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities (HAs)
Maintain appropriate external contacts and negotiate with HAs (U.S., EU, PMDA, and others) to obtain timely registration of the diagnostic products
Provide guidance, support, and educational training to pharmaceutical project teams regarding in vitro diagnostic regulations and regulatory strategy
Draft and/or review the U.S. and EU Study Risk Determinations for the investigational diagnostic products used in the therapeutic product clinical studies
In partnership with the diagnostic test provider, handle the timely coordination, compilation, and submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities. This includes, but is not limited to, submission of CDRH Q-submissions (study risk determination requests and pre-submission meeting requests), CDRH Investigational Device Exemptions, EU IVDR Performance Study Applications, and diagnostic product marketing authorization submissions
Track Requests for Information (RFI) received from regulatory authorities related to diagnostic product submissions and manage the cross-functional responses to the RFI
Communicate with regulatory authorities and notified bodies to expedite approval of diagnostic regulatory submissions
Participate in therapeutic product Global Regulatory Team (GRT) meetings and provide updates to the teams regarding diagnostic product deliverables and timelines
Participate in cross-functional diagnostic team meetings and meetings with the external diagnostic test providers to track and monitor deliverables
Collaborate with GRA colleagues to document and comply with diagnostic product requirements globally
Monitor current and pending approvals in specific therapeutic/companion diagnostic/medical device areas and be knowledgeable of laws, directives, guidance(s) and requirements related to those areas
Provide assessments of the impacts of new and changing regulations on the company objectives to project and management teams
Support GRA Diagnostics in becoming a first-in-class organization by working internally and externally (i.e., participating in working groups, consortia, and trade associations, such as AdvaMed) to shape regulatory framework, identify process improvements
Qualification
Required
A minimum of a Bachelor's degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or a health-related discipline is required
A minimum of 10 years of experience in a decision-making role on a pharmaceutical therapeutic team is required
A minimum 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q-Sub, IDE, 510k, PMA) and EU CE Conformity Certification marking is required
A minimum of 5 years of translational science experience working with diagnostic test providers is required
Strong experience with regulatory submissions and communication with Health Authorities is required
Strong understanding of medical device development is required
Proficient understanding of in vitro diagnostic technologies is required
Experience successfully working within a cross-functional team environment as a contributor, decision maker, and creator of innovative regulatory strategies is required
Must have excellent verbal and written communication skills
Must have strong analytical and strategic thinking skills
Must be flexible and innovative with the ability to work in a changing, complex, and ambiguous environment
Must have the ability to work independently, managing daily activities and project deliverables with limited management oversight
The ability to present complex information to cross-functional project teams and senior management in a clear and concise manner is required
The ability to identify regulatory risks and mitigations is required
The ability to collaborate with all levels across a matrix organization is required
Preferred
Advanced degree (Master's, PharmD, PhD) preferred
Knowledge of the drug development process is preferred
Knowledge of therapeutic product regulations is preferred
Regulatory Affairs Certification (RAC) is preferred
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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