Sr. Manager, Regulatory Affairs

Location: Raritan New Jersey West Chester Pennsylvania Palm Beach Gardens Florida Raynham Massachusetts Warsaw Indiana

DePuy Synthes is recruiting for a(n) Sr. Manager Regulatory Affairs.

Johnson & Johnson announced plans to separate our Orthopedics business toestablisha standalone orthopedics companyoperatingas DePuy 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 role leads the technology product strategy and deliveryforRegulatory Affairsfocused digital capabilities across DePuy Synthes. The Sr. Manager serves as the product owner for critical regulatory technology platforms translating regulatory and quality needs into scalable compliant solutions that enable faster submissions stronger compliance and improved data integrity across the product lifecycle. This position has high visibility and impact partnering closely with Regulatory Affairs Quality R&DSupply Chainand IT to modernize regulatory processes and drive measurable business outcomesand reports into theDePuySynthes Technology organization.

Key Responsibilities

• Own the endtoend productlifecycle for Regulatory Affairs technology platforms from strategy and roadmap through delivery adoption and optimization.

• Partner with Regulatory Affairs Quality R&DSupply Chainand IT stakeholders to translate business needs into clear product requirements and prioritized backlogs.

• Define andmaintaina multiyear product roadmap aligned with regulatory strategy compliance obligations and enterprise architecture standards.

• Ensure solutions meet global regulatory quality and data integrity requirements including validation and audit readiness.

• Lead crossfunctional delivery teams using Agile and product management best practices to deliver value incrementally and predictably.

• Manage vendor and partner relationships including solution selection performance management and contract alignment.

• Establish KPIs and success metrics to measure product performance adoption and business impact.

• Provide thought leadership on digital innovation in Regulatory Affairsidentifyingopportunities to streamline processes and improve compliance outcomes.

• 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

• Required:Bachelors degree in Information Technology Engineering Life Sciences ora relatedfield.

• Preferred: Masters degree (MS MBA) or equivalent advanced degree.

Experience and Skills

Required:

• 8-10years of relevant experiencein technology product management IT delivery or digital transformation aligned to a Sr. Manager level role.

• Demonstrated experience supporting Regulatory Affairs Quality or R&D functions in a regulated environment (medical devices pharmaceuticals or life sciences).

• Strong knowledge of regulated system delivery including validation compliance and data integrity expectations.

• Proven ability to lead crossfunctional global teamsand influence without direct authority.

• Experience owning and prioritizing product backlogs and roadmaps tied to business outcomes.

• Excellent communication skills with the ability to translate complex technical topics for business audiences.

Preferred:

• Experience with regulatory information management (RIM) or submissionrelated platforms.

• Familiarity with Agile /SAFedelivery models in enterprise environments.

• Experience managing technology vendors and system integrators.

• Background in global regulatory operations and health authority interactions.

• Exposure todata analytics or automation solutions supporting regulatory processes.

Other:

• Language: English (business fluent).

• Travel: Up to 1015% primarily domestic with limited international travel.

• Certifications: Product Management Agile or Project Management certifications (preferred).

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 please contact us via or contact AskGS to be directed to your accommodation resource.

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