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Director, Reg & Scientific Affairs

$150k - $258.75k

6149-DePuy Synthes Products Inc. Legal Entity

Position Director, Regulatory & Scientific Affairs (Hybrid) – Raynham, MA (optional locations: Raritan, NJ; West Chester, PA; Warsaw, IN; Palm Beach Gardens, FL). This role is part of DePuy Synthes, a new standalone orthopedics company under Johnson & Johnson. Job Overview The Director provides strategic leadership at the intersection of regulatory affairs, scientific engagement, and R&D technology enablement. The role shapes how digital and technology solutions support regulatory compliance, scientific evidence generation, and lifecycle management for DePuy Synthes’ orthopedic portfolio. Key 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 and strengthening decision‑making while ensuring compliance. Qualifications Bachelor’s degree in Engineering, Information Technology, or a related field (advanced degree preferred). 10–12 years of experience in regulatory affairs, scientific affairs, R&D, or related technology‑enabled functions in medical devices, pharmaceuticals, or life sciences. Proven senior management or director‑level leadership with cross‑functional teams. Strong understanding of regulatory frameworks (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 outcomes. Strong executive communication, stakeholder management, and decision‑making skills. Preferred: Experience supporting medical device or life science products; familiarity with regulatory information management systems (RIMS), document management systems, data analytics platforms; digital transformation or modernization initiatives; global regulatory exposure (FDA, EU MDR/IVDR). Language proficiency in English (additional languages preferred). Travel: Up to 20% domestic and international. Certifications: PMP, Agile, or related IT certifications preferred. Compensation Base pay range: $150,000 – $258,750. Additional Information For more information on our employee support programs, visit This posting is open for applications. Please contact us for accommodations if you have a disability. Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or any other characteristic protected by law. We actively seek qualified candidates who are protected veterans and individuals with disabilities. Johnson & Johnson is committed to providing an inclusive interview process. Request accommodations for applicants with disabilities through #J-18808-Ljbffr 6149-DePuy Synthes Products Inc. Legal Entity

Vacancy posted 3 days ago
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