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 integral 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 global 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 global 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 (Ceuta)
🏢 Smartedge Solutions
📍 Ceuta