DePuy Synthes is recruiting fora(n)Director, Reg & Scientific Affairs;this Hybrid positionwill 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 toestablisha standalone orthopedics company,operatingasDePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may berequired, regulatory approvals and other customary conditions and approvals. Should you accept this position, it isanticipatedthat, following conclusion of the transaction, you would be an employee of DePuySynthesand 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 atan appropriate timeand 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 inshaping howdigital and technology solutions support regulatory compliance, scientific evidence generation, and lifecycle management for DePuy Synthes92 orthopedic portfolio. The Director partners closely with R&D, Quality,ScientificAffairs(Clinical, Pre-clinical andMedical Affairs),and IT leaders to ensuretechnologyenabledregulatory strategies that accelerate innovation whilemaintainingthe highest standards of compliance and patient safetyand reports into theDePuySynthes 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 ScientificAffairsleadership, translating business and compliance needs into scalable digital solutions.

• Oversee technology platforms supporting regulatory submissions, registrations, product dossiers, labeling, clinical and scientific content, and post91market evidence.

• Partner with Quality, Clinical,ScientificAffairs, Legal, Privacy, and IT Risk to ensure systems and data meet regulatory, validation, and audit requirements.

• Enable data integrity, traceability, and compliance across the end91to91end productlifecycle, including design controls, submissions, and post91market activities.

• Lead modernization and simplification of Regulatory & ScientificAffairstechnology 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 executive91level reporting ontechnologyrisks, roadmap progress, and investment outcomes related to Regulatory & Scientific Affairs.

• Lead, mentor, and develop a high91performing team of technology leaders, product owners, and domain experts.

• Drive continuous improvement through adoption of best practices, emerging technologies, anddatadriveninsights.

• Lead the application of AI, advanced analytics, and automation to modernize R&D platforms, accelerating product development, improving scientific and engineering insights, and strengtheningend91to91enddecision91makingwhile enabling scalable, compliant, and efficient R&D operations from discovery through lifecycle management.

Qualifications:

Education:

• Bachelor92s degreerequiredin Engineering, Information Technology, ora relatedfield.

• Advanceddegree(Master92s,MBA, or equivalent) preferred.

Experience and Skills:

Required:

• 10-12years of experience in regulatory affairs, scientific affairs, R&D, or related technology91enabled functions within medical devices, pharmaceuticals, or life sciences.

• Proven leadership experience at a seniormanageror director level, managing complex,91cross91functionalteams and programs.

• Strong understanding of regulatory frameworks91impactingMedTech (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 withRegulatory/Scientific Affairs, R&D, SupplyChainandITorganizations to deliver compliant,91value91drivenoutcomes.

• Strong executive communication, stakeholder management, and decision91making skills.

Preferred:

• Experience supportingmedicaldeviceorlife scienceproducts.

• 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: Englishproficiencyrequired;additionallanguages preferred.

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

• Certifications: PMP, Agile, or relevant IT certifications preferred but notrequired.

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

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