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Manager, Regulatory Intelligence
Johnson & JohnsonManager 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
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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
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