Director, Reg & Scientific Affairs

DePuy Synthes is recruiting for a(n) Director, Reg & Scientific Affairs; this Hybrid position will be in Raynham, MA (USA). Alternate Hybrid locations may be considered at Raritan, NJ (USA), West Chester, PA (USA), Warsaw, IN (USA), or Palm Beach Gardens, FL (USA).

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview:

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.

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 datadriven 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.

Qualifications:

Education:

• Bachelor’s degree required in Engineering, Information Technology, or a related field.

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

Experience and Skills:

Required:

• 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.

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.

Other:

• Language requirements: English proficiency required; additional languages preferred.

• Travel: Up to 20% domestic and international travel may be required.

• Certifications: PMP, Agile, or relevant IT certifications preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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 other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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