Regulatory Intelligence Manager — Global Insights

6010-Biosense Webster Inc. Legal Entity; Churwell; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

Johnson & Johnson is hiring a Manager, Regulatory Intelligence to lead global monitoring of regulatory changes and translate signals into actionable guidance across the product lifecycle.

The role requires 6–8 years in Quality/Regulatory Affairs within a regulated environment, with strong knowledge of ISO 13485, ISO 14971, EU MDR, and related standards. Collaboration across Regulatory Affairs, Quality, and safety teams is essential.

Qualifications

• Bachelor’s degree required in Engineering, Life Sciences, Quality, Regulatory Affairs, or related discipline.
• Typically 6–8 years of progressive experience in Quality, Regulatory Affairs, or Standards Compliance within a regulated industry (medical devices strongly preferred).
• Familiarity with ISO 13485, ISO 14971, IEC standards, FDA QSR, and EU MDR‑related standards.

Responsibilities

• Regulatory Intelligence & Surveillance: Lead end-to-end global monitoring of regulatory changes, guidance, and enforcement trends across key health authorities.
• Analysis & Insight Generation: Assess and interpret regulatory changes for impact to products, processes, and business strategy.
• Governance & Communication: Develop and lead forums, dashboards, and communication mechanisms to disseminate regulatory intelligence.
• Cross-Functional Partnership: Collaborate with Regulatory Affairs, Quality, Medical Safety, and business partners to translate intelligence into actionable plans.
• Continuous Improvement: Drive enhancements to the regulatory intelligence operating model and analytics.

Skills

Analytical Reasoning

Regulatory Affairs

Quality Management Systems

Data Analytics

Cross-functional Collaboration

Education

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

Master’s degree or advanced certification preferred

Job description

Johnson & Johnson is hiring a Manager, Regulatory Intelligence to lead global monitoring of regulatory changes and translate signals into actionable guidance across the product lifecycle.

The role requires 6–8 years in Quality/Regulatory Affairs within a regulated environment, with strong knowledge of ISO 13485, ISO 14971, EU MDR, and related standards. Collaboration across Regulatory Affairs, Quality, and safety teams is essential.