Sr. Source Regulatory Compliance Specialist

Johnson Johnson; Florida; On-site; USD 120,000 - 150,000; Full time

Job summary

DePuy Synthes is recruiting for a Sr. Source Regulatory Compliance Specialist, located in Palm Beach Gardens FL, Raynham MA, Warsaw IN or West Chester PA.

The Manager, Technology Regulatory Compliance, will lead compliance activities across regulatory and quality systems, partnering with Quality, Regulatory Affairs, Engineering, and IT to ensure compliant systems and processes. The role requires experience in regulated industries, strong analytical and communication skills, and the ability to

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 & inspections

Cross-functional collaboration

Risk management

Education

Bachelor's degree in regulatory affairs or related field

Advanced degree preferred

Job description

Job Function: Quality

Job Sub Function: Quality & Compliance Audit

Job Category: Professional

All Job Posting Locations: Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

DePuy Synthes is recruiting for a Sr. Source Regulatory Compliance Specialist, located in Palm Beach Gardens FL, Raynham MA, Warsaw, IN or West Chester PA.

Job Overview

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.

Key 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.

Qualifications

Education:

• Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, or related discipline (required).
• Advanced degree in a scientific, regulatory, or technical field (preferred).

Experience and Skills:

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-\u2011functional stakeholder groups.

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.

Other:

• Language: English required; additional European languages preferred.
• Travel: Moderate regional travel across EMEA.
• Certifications: Quality or Regulatory certifications preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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