Manager, Regulatory Intelligence

The Manager RegulatoryIntelligenceis responsible forleadingthe globalidentification 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 andsupportcompliance 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.

• Monitorcompetitorand industry intelligence toidentifyemerging risks and opportunities.

Analysis & Insight Generation

• Assess and interpret regulatory changes for impacttoproducts processes and business strategy.

• Lead triage and prioritization of new regulations and guidance ensuringtimelyescalation and alignment.

• Prepare clear leadership-ready intelligence reports and risk summaries.

Governance & Communication

• Develop and lead forums dashboards and communication mechanisms todisseminateregulatory 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

• Bachelors degreein Engineering Life Sciences Quality Regulatory Affairs ora relateddiscipline.

• Masters degree or advanced certification preferred.

Experience and Skills

Required:

• Typically68 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 partnercrossfunctionallyand influence without direct authority.

• Experience supporting audits inspections or regulatory interactions.

Preferred:

• Experience withinorthopedicsor complex medical device environments.

• Familiarity with ISO 13485 ISO 14971 IEC standards FDA QSR and EUMDRrelatedstandards.

• Experience leading or contributing toenterprisewidecompliance or standards governance initiatives.

• Priorpeopleleadership 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;additionallanguages a plus.

• Travel:Moderatedomesticand occasional international.

• Certifications: ASQ RAC or equivalent quality/regulatory certifications preferred.
  

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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.

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 via internal employees contact AskGS to be directed to your accommodation resource.

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