Director, Reg & Scientific Affairs

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 companyoperatingasDePuy 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 be 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 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 Synthes orthopedic portfolio. The Director partners closely with R&D QualityScientificAffairs(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 postmarket evidence.

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

• Enable data integrity traceability and compliance across the endtoend productlifecycle including design controls submissions and postmarket 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 executivelevel reporting ontechnologyrisks roadmap progress and investment outcomes related to Regulatory & Scientific Affairs.

• Lead mentor and develop a highperforming 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 strengtheningendtoenddecisionmakingwhile enabling scalable compliant and efficient R&D operations from discovery through lifecycle management.

Qualifications:

Education:

• Bachelors degreein Engineering Information Technology ora relatedfield.

• Advanceddegree(MastersMBA or equivalent) preferred.

Experience and Skills:

Required:

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

• Proven leadership experience at a seniormanageror director level managing complexcrossfunctionalteams and programs.

• Strong understanding of regulatory frameworksimpactingMedTech (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 compliantvaluedrivenoutcomes.

• Strong executive communication stakeholder management and decisionmaking 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 Affairsor R&D environments.

• Global regulatory exposure including FDA EU MDR/IVDR and other international authorities.

Other:

• Language requirements: Englishproficiency;additionallanguages preferred.

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

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

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

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 internal employees contact AskGS to be directed to your accommodation resource.

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