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Job Function:
Quality
Job Sub Function:
Quality & Compliance Audit
Job Category:
Professional
All Job Posting Locations:
Mooresville, Indiana, United States of America
Job Description:
DePuy Synthes is recruiting for a LOC/DC Regulatory Compliance Specialist, located in Mooresville, Indiana.
Job Overview
The LOC/DC Regulatory Compliance Specialist supports regulatory compliance activities for the Local Operating Company (LOC) and Distribution Center (DC). This role ensures that local commercial, warehousing, and distribution operations comply with applicable regulatory requirements, quality system standards, and internal policies. The position plays a key role in maintaining audit readiness, safeguarding product quality, and enabling compliant product distribution by partnering closely with Quality, Regulatory Affairs, Supply Chain, and Operations teams.
Key Responsibilities
Support regulatory compliance activities for the local operating company and distribution center in alignment with global and regional requirements.
Support schedule development of internal audits in the region, support response development, and track action to point of completion
Ensure adherence to applicable regulatory requirements, internal policies, and quality system standards across LOC/DC operations.
Partner with Quality, Regulatory Affairs, Supply Chain, and Operations teams to support compliant product storage, handling, and distribution.
Interpret regulatory and compliance requirements and translate them into local procedures and operational controls.
Support internal audits, external audits, and health authority inspections at the LOC/DC level.
Monitor compliance risks, trends, and findings and support corrective and preventive actions.
Maintainaccurateand completecompliancedocumentation, records, and reports.
Contribute to continuous improvement initiatives to strengthen local regulatory compliance and operational effectiveness.
Qualifications
Education :
Bachelor's degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, ora relateddiscipline (required).
Advanced degree in a scientific or regulatory field (preferred).
Experience and Skills :
Required:
Typically4-6years of experience in Regulatory Compliance, Quality, or related roles within a regulated industry.
Working knowledge of regulatory and quality requirementsimpactingcommercial and distribution operations.
Experience supporting audits, inspections, or compliance assessments.
Strong attention to detail with the ability to manage compliance documentation accurately.
Effective communication and cross-functional collaboration skills.
Preferred:
Experience in medical devices, healthcare, or other highly regulated industries.
Familiarity with U.S. regulatory and distribution compliance expectations.
Experience working in a global or matrixed organization.
Exposure to regulatory inspections involving distribution center operations.
Quality or Regulatory certifications (e.g., RAC, ASQ).
Other:
Language: Englishrequired.
Travel: Limited; occasional domestic travel.
Certifications: Quality or Regulatory certifications preferred but notrequired.
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.
LI-Hybrid
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)
The anticipated base pay range for this position is :
$94,000.00 - $151,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
