Manager, Regulatory Intelligence

Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category Professional All Job Posting Locations Palm Beach Gardens, Florida; Raritan, New Jersey; Raynham, Massachusetts; Warsaw, Indiana Job Description 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. Required Experience and Skills 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 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. Pay Transparency The anticipated base pay range for this position is $117,000.00 – $201,250.00. Benefits Vacation – 120 hours per calendar year Sick time – 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents) 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 (10 days) Volunteer Leave – 32 hours per calendar year Military Spouse Time‑Off – 80 hours per calendar year Equal Opportunity Employer 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. Accommodation for Disabilities 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, external applicants please contact us at jnj.com/contact-us/careers . Internally, employees may contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr Johnson & Johnson MedTech