Director, Reg & Scientific Affairs

Johnson & Johnson • West Chester, MA

5d • Hybrid

About The Position

This Director role provides strategic leadership at the intersection of regulatory affairs, scientific engagement, and R&D technology enablement. The position plays a critical role in shaping how digital and technology solutions support regulatory compliance, scientific evidence generation, and lifecycle management for DePuy Synthes’ orthopedic portfolio. The Director partners closely with R&D, Quality, Scientific Affairs (Clinical, Pre-clinical and Medical Affairs ) , and IT leaders to ensure technology ‑ enabled regulatory strategies that accelerate innovation while maintaining the highest standards of compliance and patient safety and reports into the DePuy Synthes Technology organization .

Requirements

• 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, stakeholder management, and decision ‑ making skills.
• English proficiency

Nice To Haves

• Advanced degree (Master’s, MBA , or equivalent) preferred.
• Experience supporting medical device or life science products.
• Familiarity with regulatory information management systems (RIMS), document management systems, and data analytics platforms.
• Experience leading digital transformation or modernization initiatives within Regulatory , Scientific Affairs, or R&D environments.
• Global regulatory exposure, including FDA, EU MDR/IVDR, and other international authorities.
• additional languages preferred.
• PMP, Agile, or relevant IT certifications preferred but not .

Responsibilities

• Own the R&D Technology strategy and roadmap supporting Regulatory Affairs and Scientific Affairs, aligned to business priorities and global regulatory requirements.
• Serve as the primary technology liaison to Regulatory and Scientific Affairs leadership, translating business and compliance needs into scalable digital solutions.
• Oversee technology platforms supporting regulatory submissions, registrations, product dossiers, labeling, clinical and scientific content, and post ‑ market evidence.
• Partner with Quality, Clinical, Scientific Affairs, Legal, Privacy, and IT Risk to ensure systems and data meet regulatory, validation, and audit requirements.
• Enable data integrity, traceability, and compliance across the end ‑ to ‑ end product lifecycle, including design controls, submissions, and post ‑ market activities.
• Lead modernization and simplification of Regulatory & Scientific Affairs technology landscapes, reducing complexity and technical debt while improving usability.
• Support global inspections, audits, and regulatory interactions by ensuring system readiness, documentation, and reliable access to authoritative data.
• Provide executive ‑ level reporting on technology risks, roadmap progress, and investment outcomes related to Regulatory & Scientific Affairs.
• Lead, mentor, and develop a high ‑ performing team of technology leaders, product owners, and domain experts.
• Drive continuous improvement through adoption of best practices, emerging technologies, and data  driven insights.
• Lead the application of AI, advanced analytics, and automation to modernize R&D platforms, accelerating product development, improving scientific and engineering insights, and strengthening end ‑ to ‑ end decision ‑ making while enabling scalable, compliant, and efficient R&D operations from discovery through lifecycle management.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director