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 ResponsibilitiesRegulatory 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 within orthopedics or complex medical device environments.
- Familiarity with ISO 13485, ISO 14971, IEC standards, FDA QSR, and EU MDR-related standards.
- Experience leading or contributing to enterprise-wide compliance or standards governance initiatives.
- Prior people leadership or matrix leadership experience.
- Strong analytical skills with experience using data and insights to drive compliance improvements.
- Excellent written and verbal communication skills, with the ability to translate complex requirements into clear guidance.
Other
- Language: English required; additional languages a plus.
- Travel: Moderate, domestic and occasional international.
- Certifications: ASQ, RAC, or equivalent quality/regulatory certifications preferred.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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.
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Required Skills:Preferred Skills:Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
