Medical Device Quality And Compliance Specialist

Job Title:

Medical Device Quality and Compliance Specialist

Job Description

This role focuses on ensuring the quality, safety, and regulatory compliance of medical devices through robust complaint handling, MDR reportability assessments, post-market surveillance activities, CAPA support, and audit readiness. The specialist collaborates closely with cross-functional teams in Quality, Regulatory Affairs, Clinical, R&D, Operations, and other business stakeholders to maintain compliant processes, risk-based documentation, and audit-ready records aligned with FDA expectations and 21 CFR Part 803.

Responsibilities

+ Manage and process medical device complaints in accordance with complaint-handling requirements and internal quality system procedures.

+ Perform MDR reportability assessments to determine whether events meet FDA medical device reporting criteria under 21 CFR Part 803.

+ Support post-market surveillance activities by analyzing complaint data, identifying trends, and contributing to risk-based evaluations and reporting.

+ Contribute to the development, implementation, and monitoring of Corrective and Preventive Actions (CAPA) to address product and process issues.

+ Prepare, maintain, and organize quality system documentation to ensure it is accurate, complete, and audit-ready.

+ Support audit readiness by maintaining thorough, well-documented records and providing evidence of compliance during internal and external audits.

+ Document regulatory decision rationale clearly and consistently to support MDR submissions, complaint investigations, and quality records.

+ Collaborate with Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders to ensure aligned and compliant processes.

+ Use regulatory databases, tracking tools, complaint systems, and related platforms to track cases, actions, and outcomes.

+ Participate in project coordination activities, managing multiple tasks and deadlines within a regulated environment.

+ Interpret technical, scientific, complaint, and product information and translate it into clear regulatory decisions and documentation.

+ Follow established workflows for eMDR/FDA reporting to ensure timely and accurate electronic submissions.

+ Apply risk-based documentation practices to ensure appropriate levels of detail and justification in quality and regulatory records.

Essential Skills

+ Proven experience in medical device complaint handling and MDR reportability assessments.

+ Practical exposure to FDA medical device reporting expectations and 21 CFR Part 803 requirements.

+ Hands-on experience with quality system documentation and audit-ready recordkeeping in a regulated environment.

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Experience with eMDR/FDA reporting workflows and understanding of regulatory decision rationale.

+ Strong technical writing skills with the ability to create clear, accurate, and compliant documentation.

+ Strong analytical thinking and attention to detail in evaluating complaints, risks, and regulatory requirements.

+ Demonstrated ability to prioritize, organize, and manage multiple deadlines in a fast-paced, regulated setting.

+ Ability to interpret technical, scientific, complaint, and product information and translate it into regulatory decisions or documentation.

+ Proficiency with Microsoft Office, including Excel, Word, and PowerPoint.

+ Experience using regulatory databases, tracking tools, and complaint systems.

+ Knowledge and use of SAP and Track Wise or similar quality and complaint management systems.

+ Familiarity with FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related systems where applicable.

Additional

Skills & Qualifications

+ Experience working within cross-functional teams including Quality, Regulatory Affairs, Clinical, R&D, Operations, and business stakeholders.

+ Background in medical device quality assurance, audit support, and regulatory compliance.

+ Experience contributing to Corrective and Preventive Action (CAPA) programs.

+ Exposure to risk-based documentation practices within a quality management system.

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Experience with RIMS or similar regulatory information management systems.

+ Strong project coordination skills and comfort working under tight timelines.

+ Excellent written and verbal communication skills suitable for a regulated environment.

Work Environment

This role is based within a large medical device organization and operates as part of a sizable, collaborative team. The environment is fast-paced, with tight deadlines and frequently changing day-to-day priorities. You will work extensively with digital tools and systems, including Microsoft Office, regulatory databases, tracking tools, complaint systems, SAP, Track Wise, RIMS, FDA eSTAR, ESG/eMDR workflows, and GUDID/UDI-related platforms where applicable.

The position requires comfort working in a structured, highly regulated setting with a strong focus on documentation accuracy, compliance, and continuous communication across multiple functions.

Job Type & Location

This is a Contract position based out of…