Sr. Source Regulatory Compliance Specialist

Johnson & Johnson Innovative Medicine • Warsaw, IN

1d • Hybrid

About The Position

The Manager, Technology Regulatory Compliance, is responsible for leading compliance activities related to technical and regulatory requirements across the organization in support of product and non-products systems. This role ensures that technical processes, documentation, and system implementations align with applicable regulatory standards, quality system requirements, and internal policies. The position plays a critical role in managing compliance risk, conducting audits and assessments, supporting audit inspection readiness, and enabling compliant execution of technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, and IT teams.

Requirements

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or related discipline (required).
• 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.
• English required.

Nice To Haves

• Advanced degree in a scientific, regulatory, or technical field (preferred).
• Experience in medical devices, healthcare, or other highly regulated industries.
• Familiarity with EMEA regulatory and technical compliance frameworks.
• Experience working in a global or matrixed organization.
• Exposure to regulatory inspections involving technical or system compliance.
• Quality or Regulatory certifications (e.g., RAC, ASQ).
• Strong analytical, risk‑management, and problem‑solving skills.
• Effective written and verbal communication skills.
• Additional European languages preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior