LOC/DC Regulatory Compliance Specialist

Johnson & Johnson Innovative Medicine • Mooresville, IN

5d • $94,000 - $151,800 • Onsite

About The Position

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.

Requirements

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Supply Chain, or a related discipline (required).
• Typically 4-6 years of experience in Regulatory Compliance, Quality, or related roles within a regulated industry.
• Working knowledge of regulatory and quality requirements impacting commercial 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.
• English required.

Nice To Haves

• Advanced degree in a scientific or regulatory field (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).
• Quality or Regulatory certifications preferred but not required.

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.
• Maintain accurate and complete compliance documentation, records, and reports.
• Contribute to continuous improvement initiatives to strengthen local regulatory compliance and operational effectiveness.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level