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MSD

Quality Systems & Compliance Specialist

MSD

. Support the MDCP Complaints team and other Device Regulatory & Quality Systems tasks and priorities .

Posted 11/5/2026full-timeUnited StatesJunior💰 $87,300 - $137,400 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Regulatory Compliance and Quality Systems within the medical device industry, with a strong focus on complaint handling, risk management, and technical documentation. Proficient in collaborating across cross-functional teams to ensure adherence to applicable regulations and effective communication.

Highest-signal resume keywords
Regulatory CMC ExperienceQuality Systems KnowledgeComplaint Handling InvestigationRisk Management ExperienceTechnical Writing Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory ComplianceQuality AssuranceTechnical Documentation ReviewRoot Cause AnalysisRisk ManagementComplaint InvestigationData ManagementSAP ECCSAP PLMVeeva Quality Vault
Soft Skills
Interpersonal SkillsCreative ThinkingResourcefulnessFlexibilityTeam Collaboration
Tools & Technologies
SAPSharePointLMS Training System
Industry Keywords
Medical Device Regulations21 CFR 820EU MDRISO 13485:2016ISO 14971:2012Combination Product RegulationsPost Market Safety Reporting

Tech Stack

Tools & technologies
Vault

About the role

Key responsibilities & impact
  • Support the MDCP Complaints team and other Device Regulatory & Quality Systems tasks and priorities
  • Review reportable external customer complaints for appropriateness for health authority submission
  • Review and approve documentation in the complaint database
  • Collaborate with Site Complaint Investigating Unit and Device Technical Operations on root cause analysis
  • Ensure device and device components are considered in investigations and manufacturing or packaging root cause assessments
  • Collaborate on corrective and preventive actions for external customer complaints
  • Review Device Risk Management Files for appropriate representation of investigated complaints
  • Collaborate with Device to update Device Risk Management Files as needed
  • Review and approve reportable external customer complaint investigation reports before health authority submission
  • Maintain MDCP data across SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vault systems
  • Coordinate and approve Quality-role creations and changes to SAP master data field ZZMAT_MDCP_ID
  • Submit SAP post-approval updates to the GCM TW team for MDCP identifier updates
  • Maintain SAP access and role mapping for the Device Quality & Regulatory Complaints team
  • Support the team as LMS training system steward
  • Maintain team SharePoint sites
  • Maintain the MDCPQ mailbox and associated activities
  • Maintain metrics and reporting for MDCP deviations, changes, CAPAs, and complaints
  • Interact with cross-functional teams and sites

Requirements

What you’ll need
  • 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields
  • Bachelor’s degree in Science, Engineering, Health Care, STEM or related technical field
  • Ability to work effectively in teams
  • Ability to work independently within a cross-functional framework
  • Detailed technical writing and review skills
  • Creative thinking, resourcefulness, and networking skills
  • Excellent interpersonal relationship skills
  • Flexibility to adapt to a fast-paced environment with changing priorities
  • Ability to work in a matrix organization
  • Effective written and oral communication
  • Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016) preferred
  • Risk Management Experience (ISO 14971:2012) preferred
  • Experience in Complaint Handling investigation process preferred
  • Understanding of Combination Product regulations (21 CFR Part 4, including Post Market Safety Reporting requirements) preferred
  • Must be a US or Puerto Rico resident
  • No visa sponsorship
  • No relocation

Benefits

Comp & perks
  • Annual bonus eligibility
  • Long-term incentive eligibility, if applicable
  • Medical, dental, and vision healthcare
  • Other insurance benefits for employee and family
  • Retirement benefits, including 401(k)
  • Paid holidays
  • Vacation
  • Compassionate and sick days
  • Hybrid work arrangement
  • 10% travel requirements