Director, Reg & Scientific Affairs

Johnson & Johnson Johnson & Johnson · Pharma · Raynham, MA +7

Director, Reg & Scientific Affairs role at Johnson & Johnson (DePuy Synthes) focused on shaping how digital and technology solutions support regulatory compliance, scientific evidence generation, and lifecycle management for orthopedic products. The role involves owning the R&D Technology strategy and roadmap, serving as a liaison between business and IT, and overseeing technology platforms for submissions, registrations, and post-market evidence. It also includes leading the application of AI, advanced analytics, and automation to modernize R&D platforms and drive continuous improvement. Requires strong leadership and experience in regulatory affairs/scientific affairs/R&D technology within life sciences.

What you'd actually do

  1. Own the R&D Technology strategy and roadmap supporting Regulatory Affairs and Scientific Affairs, aligned to business priorities and global regulatory requirements.
  2. Serve as the primary technology liaison to Regulatory and Scientific Affairs leadership, translating business and compliance needs into scalable digital solutions.
  3. Oversee technology platforms supporting regulatory submissions, registrations, product dossiers, labeling, clinical and scientific content, and post‑market evidence.
  4. Partner with Quality, Clinical, Scientific Affairs, Legal, Privacy, and IT Risk to ensure systems and data meet regulatory, validation, and audit requirements.
  5. Enable data integrity, traceability, and compliance across the end‑to‑end product lifecycle, including design controls, submissions, and post‑market activities.

Skills

Required

  • Bachelor’s degree 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

Nice to have

  • Advanced degree (Master’s, MBA, or equivalent) preferred

What the JD emphasized

  • regulatory compliance
  • patient safety
  • global regulatory requirements
  • regulatory affairs
  • scientific affairs
  • regulatory
  • compliance
  • regulatory frameworks
  • regulatory and scientific requirements
  • compliant