LOCDC Regulatory Compliance Specialist

DePuy Synthes is recruiting foraLOC/DC Regulatory Compliance Specialistlocatedin 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 operationscomply withapplicable regulatory requirements quality system standards and internal policies. The position plays a key role inmaintainingaudit 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:

• Bachelors 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:

:

• 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 crossfunctional 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: English.

• Travel: Limited; occasional domestic travel.

• Certifications: Quality or Regulatory certifications preferred but not.

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

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 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 internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers