Senior Technology Regulatory Compliance Lead

Johnson & Johnson MedTech; Warsaw (IN); On-site; USD 95,000 - 125,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Sr. Source Regulatory Compliance Specialist to lead regulatory compliance activities across technology areas. The role collaborates with Quality, Regulatory Affairs, Engineering, and IT to ensure compliant systems and processes.

Responsibilities include audits, risk monitoring, and facilitating inspection readiness. The ideal candidate has 6–8 years in regulatory compliance within a regulated industry, with strong knowledge of quality systems and a track

Qualifications

• Bachelor degree required.
• Advanced degree preferred.
• 6–8 years of progressive experience in Regulatory Compliance, Quality Systems, Engineering, or related roles.

Responsibilities

• Lead technology regulatory compliance activities ensuring adherence to regulatory and quality system requirements.
• Provide compliance oversight for technology processes, systems, and documentation.
• Interpret regulatory and technical standards and translate into actionable requirements.
• Partner with Quality, Regulatory Affairs, Engineering, and IT teams.
• Conduct internal and external audits and support inspections by health authorities.

Skills

Regulatory compliance

Quality systems

Audits & inspections

Cross-functional collab

Education

Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or related discipline

Advanced degree in a scientific, regulatory, or technical field

Job description

Johnson & Johnson MedTech is seeking a Sr. Source Regulatory Compliance Specialist to lead regulatory compliance activities across technology areas. The role collaborates with Quality, Regulatory Affairs, Engineering, and IT to ensure compliant systems and processes.

Responsibilities include audits, risk monitoring, and facilitating inspection readiness. The ideal candidate has 6–8 years in regulatory compliance within a regulated industry, with strong knowledge of quality systems and a track