Director, Regulatory & Scientific Affairs

Johnson & Johnson

Director providing strategic leadership in regulatory and scientific affairs for DePuy Synthes. Overseeing technology solutions to support compliance and innovation in orthopedic portfolio.

Posted 6/30/2026full-timeRaynham • Florida, Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesLead💰 $150,000 - $258,750 per yearWebsite

About the role

Key responsibilities & impact

Provides strategic leadership at the intersection of regulatory affairs, scientific engagement, and R&D technology enablement
Shapes how digital and technology solutions support regulatory compliance, scientific evidence generation, and lifecycle management for DePuy Synthes’ orthopedic portfolio
Partners closely with R&D, Quality, Scientific Affairs, and IT leaders to ensure technology-enabled regulatory strategies
Owns the R&D Technology strategy and roadmap supporting Regulatory Affairs and Scientific Affairs
Oversees technology platforms supporting regulatory submissions, registrations, product dossiers, labeling, and post-market evidence
Leads modernization and simplification of Regulatory & Scientific Affairs technology landscapes
Provides executive-level reporting on technology risks, roadmap progress, and investment outcomes

Requirements

What you’ll need

Bachelor’s degree required in Engineering, Information Technology, or a related field
10 -12 years of experience in regulatory affairs, scientific affairs, R&D, or related technology-enabled functions within medical devices, pharmaceuticals, or life sciences
Proven leadership experience at a senior manager or director level, managing complex, cross-functional teams and programs
Strong understanding of regulatory frameworks impacting MedTech (e.g., FDA, EU MDR, ISO standards) and their technology implications
Demonstrated ability to translate regulatory and scientific requirements into scalable technology solutions
Experience partnering with Regulatory/Scientific Affairs, R&D, Supply Chain and IT organizations to deliver compliant, value-driven outcomes
Strong executive communication, stakeholder management, and decision-making skills
English proficiency required; additional languages preferred

Benefits

Comp & perks

Inclusive work environment
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory ComplianceScientific Evidence GenerationR&D Technology EnablementTechnology Risk ManagementRegulatory SubmissionsProduct Dossier ManagementLabeling CompliancePost-Market Evidence ManagementISO Standards KnowledgeFDA Regulations Knowledge

Soft Skills

Stakeholder ManagementDecision-MakingStrategic LeadershipExecutive Reporting