About Careertakes

👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA — Pharma, Chemical, and Medical Devices.

Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.

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Overview

Confidential Client is seeking a Complaints Specialist experienced with ETQ workflows and MDR/eMDR regulatory reporting to join their Scientific & QA team. This role owns complaint remediation activities including ETQ review, complaint coding, investigation support, and regulatory reporting for medical-device, pharma, or chemical product domains. Candidates with 2+ years (entry-level) to senior-level experience are encouraged to apply.

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What You’ll Do

• Follow and execute the established complaint handling process and complaint lifecycle in ETQ (or equivalent QMS).
• Perform ETQ reviews and manage complaint records, including historical remediation for up to ~5 years of records.
• Prepare and support MDR / eMDR regulatory reporting and liaise with regulatory/quality teams as needed.
• Conduct complaint investigations and data analysis to determine root cause and corrective actions.
• Assign and verify complaint coding, classification, and trending for Quality/RA reporting.
• Document investigation findings, write clear technical summaries, and escalate where appropriate.
• Collaborate with Engineering, RA/QA, Manufacturing, and Customer Support to resolve complaints and implement CAPAs.
• Support audit readiness by maintaining accurate records and traceability for complaint remediation activities.

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Qualifications

• Education: Bachelor’s degree + 2 years relevant experience, OR Associate’s degree + 4 years, OR High School/GED + 6 years relevant experience.
• Engineering background required (or closely related technical discipline).
• Domain experience in Medical Devices, Pharma, or Chemical industries.
• Hands-on experience with complaint remediation, complaint coding, and regulatory reporting.
• Familiarity with ETQ or similar QMS platforms; ability to navigate and review complaint records efficiently.
• Strong written and verbal communication skills; able to prepare concise regulatory/technical documentation.
• Strong attention to detail, organization, and ability to manage multiple records and priorities.

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Preferred / Nice-to-Have

• Prior experience preparing MDR/eMDR reports for medical devices.
• Knowledge of 21 CFR Part 820, ISO 13485, and general medical device regulatory requirements.
• Experience with complaint trending, root-cause analysis, and CAPA processes.
• Prior contractor experience performing large-scale complaint remediation projects is a plus.

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Compensation & Logistics

• Estimated pay: $77,503 per year (estimated).
• Employment type: Full-time (contractor engagements may be used depending on project needs).
• Location: US (work location or remote/onsite details to be confirmed by Confidential Client).
• This posting follows standard US hiring requirements and the Confidential Client will comply with applicable state and federal employment laws.

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Why Join (What We Offer)

• Work on high-impact complaint remediation and regulatory reporting projects across medical device/pharma domains.
• Opportunity to broaden regulatory reporting and QMS (ETQ) experience.
• Cross-functional collaboration with engineering, quality, and regulatory teams.
• Exposure to audit-ready processes and improvement initiatives.

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Equal Opportunity & Hiring Transparency

Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.

If you have questions about how your data is used, please contact us directly.