Aylin Canlar
West Caldwell,NJ
Summary
Experienced Post-Market Surveillance quality leader specializing in complaint handling, global vigilance, and regulatory compliance. Guides safety and reporting decisions for high-risk complaints while improving cycle times and ensuring timely, compliant submissions. Utilizes data-driven insights and cross-functional collaboration to enhance product safety and quality systems.
Overview
18
18
years of professional experience
Work History
Manager, Regulatory Affairs
West Pharmaceutical Services
Exton, PA
10.2022 - 09.2025
- Led regulatory intelligence and signal detection efforts, identifying safety trends such as [specific safety trends] prior to market impact and advising stakeholders on clinical and regulatory risk mitigation strategies.
- Conducted clinical safety evaluations, risk assessments, and predictive trend analyses to proactively mitigate [Number] emerging health risks, resulting in a [Percentage]% decrease in adverse events and strengthening regulatory decision making.
- Conducted gap assessments to identify deficiencies in submission documentation, enhancing compliance with FDA/ICH requirements.
- Proactively tracked and managed regulatory commitments, submission timelines, and inspection readiness activities using RIMS, facilitating timely submissions.
- Authored and reviewed regulatory documentation, including PMSR and PSURs, contributing to zero audit findings and leading a high-performing regulatory team to maintain regulatory and quality standards.
- Led global cross-functional initiatives to optimize complaint management processes, reducing backlog by over 90% within six months, and implemented harmonized Post-Market Surveillance (PMS) procedures, ensuring consistent regulatory compliance.
Manager, Post-Market Surveillance
Apex Medical Corporation
Clearwater, FL
04.2021 - 10.2022
- Conducted clinical evaluations and post-market analysis, leveraging adverse event trends to drive risk mitigation and reduce field complaints by 35%.
- Managed post-market complaints and regulatory reporting, achieving 100% on-time global vigilance submissions.
- Monitored global signal detection and regulatory intelligence, advising stakeholders on clinical and compliance risks to guide strategic decisions.
- Collaborated with cross-functional teams during FDA inspections and regulatory audits, resulting in zero observations.
- Developed and mentored high-performing PMS team, improving operational efficiency and maintaining adherence to regulatory timelines.
Complaints Supervisor
Getinge (formerly Magnet)
Wayne, NJ
05.2019 - 04.2021
- Led global complaint operations, reducing backlog 90% through workflow optimization.
- Analyzed complaint trends; collaborated with Regulatory, Quality, Engineering teams to enhance post-market compliance and drive continuous improvement initiatives.
- Assessed product/process changes for regulatory impact; coordinated cross-functional approvals through electronic change management systems to ensure compliance.
- Delivered medical device vigilance training to enhance regulatory compliance and support successful inspections.
- Managed team of 15, achieving 128% of annual business objectives, and improving operational performance and KPIs.
Medical Complaints Analyst
Diagnostics Stage Inc.
Parsippany, NJ
01.2017 - 05.2019
- Oversaw end-to-end complaint lifecycle, achieving 100% compliance with ISO 13485:2016 and FDA QMSR.
- Managed 500+ annual IVD product complaints, ensuring adherence to FDA regulations and ISO standards, safeguarding product safety.
- Conducted investigations and risk assessments to assess product safety and identify measures to mitigate potential health hazards.
- Collaborated with Quality and Clinical teams on root cause investigations, achieving 100% on-time MDR and vigilance submissions.
Quality Complaint RN
Lifebelt Corporation
Branchburg, NJ
11.2015 - 12.2016
- Evaluated complex donor and clinical records to determine medical suitability for Human Cells, Tissues, and Cellular and Tissue-Based Product donation, achieving 100% compliance with FDA 21 CFR Part 1271 and AATB standards while mitigating biohazard and contamination risks.
- Directed root cause investigations for high-risk tissue and graft complaints, conducting Health Hazard Evaluations (HHE) to ensure 100% compliance with FDA 21 CFR Part 1271 and AATB standards.
- Applied clinical expertise in MDR and Vigilance assessments for IVD portfolios, ensuring 100% compliance with FDA QMSR, ISO 13485, and 21 CFR 803.
Registered Nurse/Charge Nurse
Saint Barnabas Medical Center
Livingston, NJ
05.2007 - 11.2015
- Delivered peri-operative care in high-acuity environments, ensuring adherence to departmental SOPs, TJC standards, and infection control protocols to enhance patient safety across all phases of surgical care.
- Guided clinical escalation during high-acuity cases, reinforcing adherence to surgical safety protocols and supporting staff decision-making to mitigate risks.
- Managed daily unit operations as Charge Nurse, overseeing resource allocation and risk mitigation strategies to sustain compliance with patient safety benchmarks and optimize surgical flow.
Education
Registered Nurse (R.N.) Diploma -
Holy Name Hospital School of Nursing
Bachelor of Arts (B.A.) - Sociology
Montclair State University
Skills
- Post-Market Clinical & Safety Surveillance
- Clinical Complaint Handling & Adverse Event Reporting
- Risk Management & Mitigation (ISO 14971, 13485)
- FDA Medical Device Regulations (21 CFR 803, 806, 820)
- EU Medical Device Regulations (EU MDR, MDCG, MEDDEV)
- CAPA Management & Root Cause Investigation
- Trend Analysis & Quality Reporting
- Team Leadership & Development
- Cross-functional Leadership
- Gap Analysis & Process Standardization
Professional Highlights
- Global Compliance Strategy: Reduced complaint backlog by 90%+ and harmonized post-market surveillance processes with FDA QMSR and EU IVDR requirements.
- Clinical Risk Oversight: Led Health Hazard Evaluations (HHEs) and advanced trend analysis to proactively mitigate patient safety risks and support regulatory decision-making.
- Audit Readiness: Achieved zero findings across 5+ FDA and Notified Body inspections through sustained inspection readiness and robust quality systems.
- Organizational Scaling: Built and scaled global Quality and Regulatory teams, surpassing performance targets by 128% while strengthening engagement and accountability.
Timeline
Manager, Regulatory Affairs
West Pharmaceutical Services
10.2022 - 09.2025
Manager, Post-Market Surveillance
Apex Medical Corporation
04.2021 - 10.2022
Complaints Supervisor
Getinge (formerly Magnet)
05.2019 - 04.2021
Medical Complaints Analyst
Diagnostics Stage Inc.
01.2017 - 05.2019
Quality Complaint RN
Lifebelt Corporation
11.2015 - 12.2016
Registered Nurse/Charge Nurse
Saint Barnabas Medical Center
05.2007 - 11.2015
Registered Nurse (R.N.) Diploma -
Holy Name Hospital School of Nursing
Bachelor of Arts (B.A.) - Sociology
Montclair State University