Associate Director, Global Regulatory Affairs Diagnostics

Role Summary

Associate Director, Global Regulatory Affairs Diagnostics. Hybrid role located in Raritan, NJ or Spring House, PA, with potential remote options on case-by-case basis. Supports in vitro diagnostics Regulatory Affairs, including companion diagnostics, in support of Johnson & Johnson therapeutic product development.

Responsibilities

• Contribute to regulatory strategies for diagnostic products related to therapeutic product development.
• Oversee coordination and compilation of global submissions for In Vitro Diagnostics (IVD) and Medical Devices (MD) to Health Authorities.
• Maintain external contacts and negotiate with Health Authorities to obtain timely registration of diagnostic products.
• Provide guidance and training to project teams on in vitro diagnostic regulations and regulatory strategy.
• Draft and/or review U.S. and EU study risk determinations for investigational diagnostic products.
• Coordinate and submit investigational and new in vitro diagnostic medical device applications to regulatory authorities (e.g., CDRH submissions, EU IVDR applications).
• Track RFIs from regulatory authorities and manage cross-functional responses.
• Communicate with regulatory authorities and notified bodies to expedite approvals.
• Participate in Global Regulatory Team meetings and provide updates on diagnostic deliverables and timelines.
• Collaborate with diagnostic teams and external providers to track deliverables.
• Document and comply with diagnostic product requirements globally with GRA colleagues.
• Monitor current/pending approvals and stay informed on relevant laws and directives.
• Assess regulatory impacts of new regulations and advise management teams.
• Support GRA Diagnostics in shaping regulatory framework and process improvements through external collaborations.

Qualifications

• Bachelor’s degree in Biochemistry, Microbiology, Pharmacy, Life Sciences or health-related field; advanced degree preferred.
• Minimum 10 years in a decision-making pharmaceutical team role.
• Minimum 5 years of relevant diagnostics regulatory experience with U.S. submissions (Q-Sub, IDE, 510k, PMA) and EU CE marking.
• Minimum 5 years translational science experience with diagnostic test providers.
• Strong experience with regulatory submissions and communications with Health Authorities.
• Strong understanding of medical device development and in vitro diagnostic technologies.
• Regulatory Affairs Certification (RAC) preferred.
• Experience working in cross-functional teams and developing regulatory strategies.
• Excellent verbal and written communication; strong analytical and strategic thinking; ability to work independently and in a matrix environment.
• Ability to present complex information clearly to cross-functional teams and senior management; identify regulatory risks and mitigations.

Skills

• Regulatory strategy development
• Global regulatory submissions (IVD/MD)
• Health Authority communications
• Regulatory risk assessment
• Cross-functional collaboration
• Documentation and project management

Education

• Bachelor’s degree required; advanced degree preferred.

Additional Requirements

• None beyond listed qualifications.