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 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 role leads the technology product strategy and delivery for Regulatory Affairs–focused 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&D, Supply Chain, and IT to modernize regulatory processes and drive measurable business outcomes and reports into the DePuy Synthes Technology organization.

Key Responsibilities

• Own the end‑to‑end product lifecycle for Regulatory Affairs technology platforms, from strategy and roadmap through delivery, adoption, and optimization.

• Partner with Regulatory Affairs, Quality, R&D, Supply Chain, and IT stakeholders to translate business needs into clear product requirements and prioritized backlogs.

• Define and maintain a multi‑year 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 cross‑functional 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 Affairs, identifying opportunities 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 strengthening end‑to‑end decision‑making while enabling scalable, compliant, and efficient R&D operations from discovery through lifecycle management.

Qualifications

Education

• Required: Bachelor’s degree in Information Technology, Engineering, Life Sciences, or a related field.

• Preferred: Master’s degree (MS, MBA) or equivalent advanced degree.

Experience and Skills

Required:

• 8-10 years of relevant experience in 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 cross‑functional, global teams and 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 submission‑related platforms.

• Familiarity with Agile / SAFe delivery models in enterprise environments.

• Experience managing technology vendors and system integrators.

• Background in global regulatory operations and health authority interactions.

• Exposure to data, analytics, or automation solutions supporting regulatory processes.

Other:

• Language: English (business fluent).

• Travel: Up to ~10–15%, 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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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