Manager, Regulatory Intelligence

Johnson & Johnson Innovative Medicine • Warsaw, IN

1d • $117,000 - $201,250 • Hybrid

About The Position

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.

Requirements

• 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.
• 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.
• English required; additional languages a plus.

Nice To Haves

• Master’s degree or advanced certification 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.
• ASQ, RAC, or equivalent quality/regulatory certifications preferred.

Responsibilities

• 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.
• 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.
• 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.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager