Senior Manager (Product Quality Complaints & Medical Device Reporting US and Global)

Smartedge Solutions; España; Remote; EUR 90,000 - 150,000; Full time

Job summary

Smartedge Client in Spain is seeking a Senior Manager (Product Quality Complaints & MDR) for a 100% remote role. The candidate will lead PQC operations and Medical Device Reporting for US and global markets, ensuring compliant complaint intake, investigation coordination, and timely submissions.

The ideal candidate has deep regulatory experience (FDA 21 CFR Part 803, ISO 13485), hands-on MDR preparation, and the ability to mentor a cross‑functional team in a high‑volume environment while

Qualifications

• Deep regulatory experience in medical device PQC and MDR
• Hands-on experience with US FDA MDR requirements and global vigilance
• Experience leading cross-functional teams in a high-volume regulated environment

Responsibilities

• Lead PQC and MDR activities for US and global markets
• Oversee complaint intake, triage, investigation, and reporting
• Ensure compliance with 21 CFR Part 803 and ISO/GDP standards
• Coordinate global vigilance submissions and country-specific reportability criteria
• Mentor and develop a high-performing team of quality/regulatory professionals

Skills

PQC Management

MDR Expertise

FDA MDR Knowledge

Global Vigilance

Documentation & Inspection Readiness

Education

Bachelor’s degree in Life Sciences / related discipline

Associates certification in Regulatory Affairs/Quality

Tools

ETQ

TrackWise

Veeva Vault

Salesforce

Job description

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 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.