Manager, Regulatory Intelligence

Job Function

Regulatory Affairs Group

Regulatory Affairs

Professional

Palm Beach Gardens, Florida;
Raritan, New Jersey;
Raynham, Massachusetts;
Warsaw, Indiana

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.

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.

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 with in 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.

The anticipated base pay range for this position is $ – $.

• 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…