Quality Systems & Compliance Specialist - Regulatory Data

Merck; New Jersey; On-site; USD 70,000 - 95,000; Full time

Job summary

Merck in New Jersey seeks a Specialist, Quality Systems & Compliance within Device Regulatory & Quality to support the MDCP Complaints team and related systems tasks. You will interact with cross-functional teams, review documentation for compliance, and drive root-cause and CAPA activities across SAP ECC, SAP PLM, and Veeva Vaults.

The role emphasizes independent work, team collaboration, and strong writing/review skills to ensure device and regulatory requirements are met in a fast-paced

Qualifications

• 1–3 years relevant experience in Regulatory CMC, Quality, development, testing or licensure of pharmaceutical products.
• Bachelor's degree in Science, Engineering, Health Care, STEM or related technical field.
• Ability to work in teams within a cross-functional framework and write/review technical documents.
• Strong written and verbal communication with detail-oriented project coordination.
• Experience coordinating regulatory data across ERP and quality systems is a plus.

Responsibilities

• Review reportable external customer complaints for health authority submission.
• Document review/approval in complaint database.
• Collaborate with Site Complaint Investigating Unit and Device TO for root cause analysis.
• Coordinate robust corrective/preventive actions for external complaints.
• Review Device Risk Management Files to ensure accurate representation of investigations.
• Maintain MDCP data across SAP ECC, SAP PLM, and Veeva Vaults.
• Manage SAP master data field ZZMAT_MDCP_ID and related updates.
• Support LMS training system stewardship and SharePoint maintenance.
• Monitor metrics and reporting for MDCP deviations, changes, CAPAs, and complaints.

Skills

Adaptability

Complaints Investigation

Creative Thinking

Cross-Functional Teamwork

Detail-Oriented

Problem Solving

Working Independently

Education

Bachelor's degree in Science/Engineering/Health Care/STEM

Tools

SAP ECC

SAP PLM

Veeva Quality and Regulatory Vaults

Job description

Merck in New Jersey seeks a Specialist, Quality Systems & Compliance within Device Regulatory & Quality to support the MDCP Complaints team and related systems tasks. You will interact with cross-functional teams, review documentation for compliance, and drive root-cause and CAPA activities across SAP ECC, SAP PLM, and Veeva Vaults.

The role emphasizes independent work, team collaboration, and strong writing/review skills to ensure device and regulatory requirements are met in a fast-paced