Manager,Regulatory Intelligence in Leeds

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DePuy Synthes is recruiting for a position located in multiple locations including MA Raynham, FL Palm Beach Gardens, IN Warsaw, NJ Raritan, Leeds, UK or Loughbeg, Ringaskiddy. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

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: Bachelors degree required in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline. Masters 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.

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.