Manager, Regulatory Intelligence

Johnson & Johnson

Manager of Regulatory Intelligence at Johnson & Johnson overseeing regulatory changes and compliance across product lifecycles. Leading strategic insights for global regulatory requirements and risk management.

Posted 6/8/2026full-timePalm Beach Gardens • Florida, Massachusetts, New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $117,000 - $201,250 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

regulatory intelligencequality management systemscompliance frameworksdata analysisKPI trackingrisk assessmentregulatory requirements interpretationaudit supportISO 13485ISO 14971

Soft Skills

cross-functional collaborationinfluence without authorityanalytical skillswritten communicationverbal communicationleadershipreport preparationproblem-solvingstrategic thinkingstakeholder engagement

Tools & Technologies

dashboardssurveillance processesregulatory intelligence sourcescommunication mechanismsgovernance toolsdata insights toolsregulatory operating model enhancementsindustry intelligence monitoringrisk summary reportsregulatory forums

Industry Keywords

medical devicesregulatory affairsstandards complianceFDA QSREU MDRorthopedicsinternational standardsregulatory changesguidance enforcementemerging risks

About the role

Key responsibilities & impact

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.
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.
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.
Collaborate with Regulatory Affairs, Quality, Medical Safety, and business partners to translate intelligence into actionable plans.
Drive enhancements to the regulatory intelligence operating model (sources, cadence, tools, and governance).

Requirements

What you’ll need

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

Benefits

Comp & perks

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