Senior Technology Regulatory Compliance Lead

Brighter Signals; Warsaw (IN); On-site; USD 110,000 - 160,000; Full time

Job summary

Johnson & Johnson in the United States seeks a Sr. Source Regulatory Compliance Specialist to lead regulatory compliance activities for technology systems. The role partners with Quality, Regulatory Affairs, Engineering, and IT to ensure audits, inspections, and compliance controls across global sites.

You will drive risk assessments, policy implementation, and continuous improvement in a highly regulated medical devices setting.

Qualifications

• Typically 6–8 years of progressive experience in Regulatory Compliance, Quality Systems, Engineering, or related roles within a regulated industry.
• Strong working knowledge of regulatory and technical requirements impacting quality systems and processes.
• Experience supporting audits, inspections, and compliance assessments.
• Ability to manage complex technical compliance topics across cross-functional stakeholder groups.

Responsibilities

• Lead and manage technology regulatory compliance activities, ensuring adherence to regulatory and quality system requirements.
• Provide compliance oversight for technology processes, systems, and documentation supporting regulated activities.
• Interpret regulatory and technology standards and translate them into actionable compliance requirements.
• Partner with Quality, Regulatory Affairs, Engineering, and IT teams to support compliant systems and process implementation.
• Conduct internal audits, external audits, and support health authority inspections in support of product and non-product technology regulatory compliance.
• Monitor compliance risks, trends, and performance metrics; drive corrective and preventive actions.
• Ensure consistent application of global and regional compliance policies, procedures, and controls.
• Drive continuous improvement initiatives to strengthen technical compliance, governance, and effectiveness.

Skills

Regulatory compliance

Quality systems

Audits

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Regulatory Affairs

Advanced degree preferred

Job description

Johnson & Johnson in the United States seeks a Sr. Source Regulatory Compliance Specialist to lead regulatory compliance activities for technology systems. The role partners with Quality, Regulatory Affairs, Engineering, and IT to ensure audits, inspections, and compliance controls across global sites.

You will drive risk assessments, policy implementation, and continuous improvement in a highly regulated medical devices setting.