Sr. Manager, Regulatory Affairs

Johnson & Johnson Innovative Medicine • New Brunswick, NJ

2d • Hybrid

About The Position

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.

Requirements

• Bachelor’s degree in Information Technology, Engineering, Life Sciences, or a related field.
• 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.
• English (business fluent).

Nice To Haves

• Master’s degree (MS, MBA) or equivalent advanced degree.
• 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.
• Product Management, Agile, or Project Management certifications.

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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager