Sr. Source Regulatory Compliance Specialist

Johnson & Johnson MedTech; West Chester (Chester County); On-site; USD 120,000 - 150,000; Full time

Job summary

Johnson & Johnson is seeking a Sr. Source Regulatory Compliance Specialist to lead regulatory compliance activities across technology and systems.

Located in Palm Beach Gardens, FL, Raynham, MA, Warsaw, IN, or West Chester, PA, the role partners with Quality, Regulatory Affairs, Engineering, and IT to ensure compliant implementation and ongoing governance. Responsibilities include conducting audits, supporting inspections, managing risk, and driving continuous improvement of quality systems and

Qualifications

• 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

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

Job Description

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).

Required

Experience and Skills

• 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.

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 you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#DePuySynthesCareers

Required Skills

Preferred Skills

Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Communication, Compliance Management, Compliance Policies, Compliance Risk, Controls Compliance, Critical Thinking, Problem Solving, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)