Manager, Regulatory Intelligence

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America

Job Description:

* DePuy Synthes is recruiting for a Manager, Regulatory Intelligence located in Raynham, Massachusetts, Palm Beach Gardens, Warsaw, NJ RARITAN

The Manager, Regulatory Intelligence is responsible for leading the global identification, monitoring, and interpretation of evolving regulatory requirements, health authority expectations, and industry trends. This role translates external signals into actionable insights and structured intelligence that inform regulatory strategy, enable proactive risk management, and support compliance and market access across the product lifecycle.

Key Responsibilities

Regulatory Intelligence & Surveillance

* Lead end-to-end global monitoring of regulatory changes, guidance, and enforcement trends across key health authorities.

* Establish and execute structured surveillance processes across global regulatory intelligence sources.

* Monitor competitor and industry intelligence to identify emerging risks and opportunities.

Analysis & Insight Generation

* Assess and interpret regulatory changes for impact to products, processes, and business strategy.

* Lead triage and prioritization of new regulations and guidance, ensuring timely escalation and alignment.

* Prepare clear, leadership-ready intelligence reports and risk summaries.

Governance & Communication

* Develop and lead forums, dashboards, and communication mechanisms to disseminate regulatory intelligence across stakeholders.

* Define and track KPIs related to regulatory intelligence effectiveness and impact.

* Ensure consistent interpretation and alignment of regulatory requirements across functions.

Cross-Functional Partnership

* Collaborate with Regulatory Affairs, Quality, Medical Safety, and business partners to translate intelligence into actionable plans.

* Support regulatory strategy development, submission planning, and lifecycle management with forward-looking insights.

* Partner with digital and data teams to enhance intelligence tools, analytics, and reporting capabilities.

Continuous Improvement

* Drive enhancements to the regulatory intelligence operating model (sources, cadence, tools, and governance).

* Embed data-driven insights and analytics to improve forecasting, prioritization, and compliance readiness.

Qualifications

Education

* Bachelor's degree required in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline.

* Master's degree or advanced certification preferred.

Experience and Skills

Required:

* Typically 6-8 years of progressive experience in Quality, Regulatory Affairs, or Standards Compliance within a regulated industry (medical devices strongly preferred).

* Demonstrated experience interpreting and applying international standards and regulatory requirements.

* Strong understanding of quality management systems and compliance frameworks.

* Proven ability to partner cross‑functionally and influence without direct authority.

* Experience supporting audits, inspections, or regulatory interactions.

Preferred:

* Experience with in orthopedics or complex medical…