Smartedge Client is looking for an individual to help with their

Senior Manager (Product Quality Complaints & Medical Device Reporting US and Global) @ 100 % Remote work

Job Description
We are seeking someone with deep medical device Product Quality Complaint (PQC) and Medical Device Reporting (MDR) expertise. This role will manage day-to-day complaint and vigilance operations, support team capability, and maintain consistent, inspection-ready execution across complaint intake, triage, investigation coordination, reportability assessment, MDR preparation, submission, follow-up, and closure. The role requires hands-on knowledge of U.
S. FDA MDR requirements and practical experience supporting global medical device vigilance obligations across multiple markets.

Key Responsibilities
Product Quality Complaint Management Operational and subject-matter expertise across complaint intake, triage, coding, event assessment, follow-up, and closure. Ensure complaint records contain complete and accurate product, device, event, patient, outcome, reporter, investigation, and follow-up information. Support complaint remediation, retrospective review, backlog reduction, and sustained operations while maintaining quality and regulatory compliance. Lead the identification, assessment, preparation, quality review, and submission of reportable adverse event and malfunction reports in the United States and applicable global markets. Ensure U.
S. MDR decisions and submissions align with approved company procedures and applicable FDA requirements, including 21 CFR Part 803. Oversee initial, follow-up, supplemental, and corrected reports, including clear event narratives, manufacturer evaluation summaries, device information, patient outcomes, and reporting rationale.



Provide oversight for integral vigilance assessments and submissions, including country
- or region-specific reportability criteria, formats, timelines, follow-up expectations, and local affiliate coordination. Bachelor’s degree or Associates certification in Life Sciences, Nursing, Pharmacy, Regulatory Affairs, Quality, or a related discipline; advanced degree is a plus. Significant medical device industry experience in product quality complaints, post-market surveillance, vigilance, regulatory reporting, or quality operations. Demonstrated people-management experience leading complaint, quality, regulatory, safety, or vigilance professionals in a high-volume regulated environment. Hands-on experience identifying potentially reportable events and preparing, reviewing, and submitting U.
S. MDRs and general medical device vigilance reports. Strong working knowledge of medical device complaint handling, reportability assessment, investigation documentation, Good Documentation Practices, and inspection readiness. Working knowledge of 21 CFR Part 803, 21 CFR Part 820 / applicable Quality Management System requirements, ISO 13485, ISO 14971, and global post-market vigilance principles. Experience with complaint or eQMS platforms such as ETQ, TrackWise, Veeva Vault, Salesforce, or comparable systems. Excellent written and verbal English communication, sound judgment, strong attention to detail, and the ability to explain complex decisions clearly to operations and leadership. Experience supporting US and multiple global regions, such as the European Union, United Kingdom, Canada, Latin America, and Asia-Pacific markets. Experience leading remediation, retrospective complaint review, Experience with health authority inspections, audit responses, CAPA execution, and formal compliance commitments.

📌 Senior Manager (Madrid)
🏢 Smartedge Solutions
📍 Madrid