Scientific Affairs Jobs (NOW HIRING)

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 Synthes' 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 postmarket 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 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:

• Bachelor's degreerequiredin Engineering, Information Technology, ora relatedfield.

• Advanceddegree(Master's,MBA, 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 complex,crossfunctionalteams 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 compliant,valuedrivenoutcomes.

• 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 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.

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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