Medical Device Complaint Specialist

Position Type: Contract (Potential Temp-to-Perm)

Location: SF Bay Area (On-site 3 days/week)

Role Overview & Key Responsibilities

• Complaint Management & Lifecycle Investigations: Oversee complete complaint handling workflows from intake to closure. Execute Good Faith Efforts (GFE) for product returns, gather clinical/field context from cross-functional teams, and perform root-cause failure analysis.
• Global Regulatory Submissions: Conduct reportability assessments and timely adverse event filings across global markets in accordance with relevant standards (US FDA 21 CFR 803 MDRs, EU MDR/MDD Vigilance, Health Canada, PMDA, and NMPA).
• Data, Trend Analysis & Recall Prevention: Track, summarize, and evaluate post-market surveillance data to identify emerging failure modes, escalating complaint trends, and potential recall triggers. Present findings and actionable recommendations during management reviews.
• Quality Engineering & Corrective Actions: Partner with Design Quality Engineering to update Risk Management files based on new failure modes or occurrence frequencies. Drive CAPAs and SCARs when complaint metrics exceed expected baselines.
• Surveillance Documentation & Audit Support: Author and maintain PMS plans, Post-Market Surveillance Reports (PMS-R), and Periodic Safety Update Reports (PSUR). Support internal and external regulatory body audits, ensuring alignment with the organization's Quality Management System (QMS) and EHS policies.
• Policy & Customer Interfacing: Draft responses to client failure analysis requests and collaborate with leadership to refine system-level procedures and quality policies.

Qualifications & Requirements

• Experience: 5+ years in medical device quality systems, with at least 5 years dedicated to post-market surveillance, complaint handling, and adverse event reporting.
• Industry Focus: Medical device background strongly preferred; pharmaceutical quality experience will also be considered.
• Regulatory Competency: Hands-on experience executing adverse event submissions for both domestic and international regulatory bodies.
• Education: Bachelor’s degree in Engineering, Life Sciences, or equivalent practical industry experience.
• Work Arrangement: SF Bay Area-based with the ability to work on-site 3 days per week.

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