Manager, Technical Regulatory Compliance
PharmaRegulatory Affairs
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, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America Job Description: DePuy Synthes is recruiting for a Manager, Technical Regulatory Compliance, located in Raynham MA or Palm Beach Gardens FL or West Chester PA. Job Overview The Manager, Technical Regulatory Compliance is responsible for leading compliance activities related to technical, system, and process regulatory requirements. This role ensures that technical operations, systems, and documentation comply with applicable regulations, quality system standards, and internal policies. The position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams. Key Responsibilities Lead and manage technical regulatory compliance activities in alignment with global and regional compliance strategies. Provide compliance oversight for technical processes, systems, and documentation supporting regulated activities. Interpret regulatory and technical standards and translate them into actionable compliance requirements. Partner with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams to support compliant system and process implementation. Support internal audits, external audits, and health authority inspections related to technical compliance. Monitor compliance risks, trends, and performance metrics and drive corrective and preventive actions. Ensure consistent application of global and site‑specific 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 a 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 manufacturing processes. Experience supporting audits, inspections, and regulatory assessments. Ability to manage complex technical compliance topics across cross‑functional stakeholder groups. Strong analytical, risk‑management, and problem‑solving skills. Effective written and verbal communication skills. Preferred : Experience in medical devices, healthcare, or other highly regulated industries. Familiarity with U.S. 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). Other : Language: English required . Travel: Limited; occasional domestic travel. Certifications: Quality or Regulatory certifications preferred but not required . For more information on how we support the whole health of
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