Nida Aksit
Istanbul,Türkiye
Summary
Regulatory Affairs and Quality Assurance Specialist with experience in the medical device industry, specializing in EU MDR 2017/745, MDD 93/42/EEC, ISO 13485:2016, technical documentation, risk management, post-market surveillance, and Notified Body audits. Currently working as a Quality Assurance Specialist and Deputy PRRC, supporting QMS compliance, Device History Record (DHR) control, CAPA, PMS/PMCF, risk management, and audit readiness across Class IIa, IIb, and III medical devices. Previous Regulatory Affairs and consultancy experience includes MDR transition, CE certification, technical documentation, country registrations and PSUR related activities. Looking to further build a career in Regulatory Affairs by leveraging regulatory and quality expertise in the European medical device industry.
Dutch and Turkish citizen, based in Istanbul and open to relocation across Europe.
Overview
3
3
Languages
1
1
Certification
6
6
years of professional experience
Work History
QUALITY ASSURANCE SPECIALIST | DEPUTY PRRC
ALSANZA MEDIZINTECHNIK UND PHARMA GMBH
Istanbul, Türkiye
03.2026 - Current
- Executed deputy PPRC responsibilities to support regulatory standards compliance through regulatory and quality checks.
- Maintained the quality management system in line with ISO 13485:2016 requirements.
- Prepared review and maintenance quality documentation and QMS process records.
- Reviewed and controlled device history records to ensure completeness, accuracy, traceability.
- Supported post-market surveillance activities and related post-market quality processes.
- Supported risk management activities in line with ISO 14971 requirements.
- Managed CAPA and nonconformity processes, including corrective and preventive actions.
- Collaborated with regulatory affairs, production management, and cross-functional teams for QMS readiness.
REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST
REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST
Istanbul, Türkiye
02.2026 - 03.2026
- Supported regulatory affairs and quality assurance under EU MDR 2017/745 and MDD 93/42/EEC.
- Supported MDR transition by updating technical and regulatory documentation against EU MDR 2017/745.
- Supported ISO 13485:2016 documentation and maintained ongoing compliance activities.
- Supported review and maintenance of technical documentation for ophthalmic and orthopedic devices.
- Supported PMCF and PSUR-related post-market surveillance compliance activities.
- Supported country-specific regulatory registrations for international markets documentation.
- Supported notified body audits by compiling preparation documents and responses.
- Supported risk management activities and maintained risk files under ISO 14971.
- Supported quality system document control, CAPA, and nonconformity management workflows.
- Supported cross-functional working with quality, regulatory affairs, production, and management teams.
REGULATORY AFFAIRS SPECIALIST
RIGICON MEDİKAL A.Ş.
Istanbul, Türkiye
01.2023 - 02.2024
- Coordinated international regulatory submissions and registrations with local market requirements.
- Led ISO 13485 quality management system activities to support FDA project and maintain documentation standards.
- Oversaw ISO 13485 QMS activities for urological medical device documentation, ensuring regulatory compliance.
- Managed technical documentation and ensured compliance with MDD to MDR transition requirements.
MEDICAL DEVICE CE CERTIFICATION SPECIALIST
TIBBİCE DANIŞMANLIK EĞİTİM & VALIDASYON HİZMETLERİ
Istanbul, Türkiye
08.2021 - 12.2022
- Supported MDR certification projects for Class IIA and Class I devices.
- Prepared and maintained technical documentation aligned with EU MDR 2017/745 requirements for multiple device categories.
- Prepared and reviewed CE certification materials for dental consumables under MDD 93/42/EEC.
- Supported CE certification compliance and technical documentation work with medical device manufacturers.
- Delivered MDR transition support via regulatory gap assessments and documentation updates including MDR Audit participation.
- Supported manufacturers during MDD surveillance audits by reviewing technical and quality files.
- Prepared FDA 510(k) regulatory documentation for selected related submissions.
QUALITY ASSURANCE SPECIALIST
PROGROUP INTERNATIONAL / PROCATH TIBBİ ÜRÜNLER / C
Istanbul, Türkiye
11.2020 - 07.2021
- Supported quality management system documentation preparation for ISO 13485:2016 compliance.
- Assisted with ISO 13485 QMS document control and quality assurance activities.
- Supported quality and regulatory documentation throughout the CE certification process.
- Prepared and supported technical documentation for CE certification under MDD 93/42/EEC.
- Supported certification activities for 189 medical devices assessed by three notified bodies.
Education
Bachelor of Science - Biomedical Engineering
T.C. Yeditepe University
Istanbul01-2020
Skills
- Regulatory compliance
- Quality management
- Technical documentation
- Risk management
- ISO 13485 compliance
- Technical Documentation / Technical Files
- Risk Management / ISO 14971
- Post-Market Surveillance (PMS)
- Periodic Safety Update Reports (PSUR)
- Clinical Evaluation Reporting
- Free Sale Certificates
- CAPA management
- PRRC Support
- EU MDR 2017/745
- MDD 93/42/EEC
- Country Registrations
- CE Certification
- EUDAMED
- MS Office
Languages
Turkish
First Language
English
Advanced
C1
Dutch
Advanced
C1
Certification
- Republic of Turkey Ministry of Health- Responsible Manager Certificate
- Republic of Turkey Ministry of Health- Sales and Promotion Personnel Certificate
- Republic of Turkey Ministry of Health- Clinical Support Personnel Certificate
- Republic of Turkey Ministry of Health- Medical Device Registration Personnel Certificate
Congress
International Congress Experience
ESCRS Congress – Copenhagen, Denmark (2025) | London, UK (2026)
Provided cross-functional support to the Sales & Marketing team during the ESCRS Congresses in Copenhagen and London, contributing to company representation and interactions with international stakeholders in the ophthalmic medical device sector.
Timeline
QUALITY ASSURANCE SPECIALIST | DEPUTY PRRC
ALSANZA MEDIZINTECHNIK UND PHARMA GMBH
03.2026 - Current
REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST
REGULATORY AFFAIRS & QUALITY ASSURANCE SPECIALIST
02.2026 - 03.2026
REGULATORY AFFAIRS SPECIALIST
RIGICON MEDİKAL A.Ş.
01.2023 - 02.2024
MEDICAL DEVICE CE CERTIFICATION SPECIALIST
TIBBİCE DANIŞMANLIK EĞİTİM & VALIDASYON HİZMETLERİ
08.2021 - 12.2022
QUALITY ASSURANCE SPECIALIST
PROGROUP INTERNATIONAL / PROCATH TIBBİ ÜRÜNLER / C
11.2020 - 07.2021
Bachelor of Science - Biomedical Engineering
T.C. Yeditepe University