Марія

Post-Market Surveillance Specialist, 128 000 грн

Розглядає посади:
Post-Market Surveillance Specialist, Quality and Regulatory Operations, QMS Administrator, Quality Coordinator, Compliance Specialist, Knowledge Management, Learning and development, Account manager, Partner Operations, Product Support and Operations
Вид зайнятості:
повна, неповна
Вік:
28 років
Місто проживання:
Інші країни
Готовий працювати:
Дистанційно

Контактна інформація

Шукач вказав: ТелефонЕл. поштуLinkedInМесенджер

Прізвище, контакти та світлина доступні тільки для зареєстрованих роботодавців. Щоб отримати доступ до особистих даних кандидатів, увійдіть як роботодавець або зареєструйтеся.

Досвід роботи

Self-employed

з 04.2026 по нині (6 місяців)
MK, Дистанційно (Медицина, охорона здоров'я, аптеки)

- Working on short- and medium-term assignments with multiple clients on a self-employed basis, while looking for a full-time role.

Tier 2 Advanced Investigations Specialist — Advanced Support & Quality

з 12.2025 по 04.2026 (5 місяців)
3Shape Ukraine, Дистанційно (Медицина, охорона здоров'я, аптеки)

Danish medtech company providing digital dentistry software and hardware solutions used by dental professionals worldwide.

Responsibilities:

- Investigated complex software and workflow failures, performing root-cause analysis and coordinating cross-functional investigations with Engineering and Product teams.
- Reviewed technical logs, patient case data and case documentation to assess product-related issues and ensure complete, appropriate information was available for investigation and escalation.
- Identified potential vigilance cases and ensured appropriate escalation in accordance with internal regulatory procedures.
- Collected, reviewed and maintained case documentation in accordance with internal procedures and regulatory requirements, ensuring complete and traceable records within CRM systems.
- Collaborated with Quality, R&D and Product Management on product investigations and performance monitoring, identifying recurring software and workflow issues and contributing findings to product and process improvements.

Пауза в карʼєрі

з 04.2024 по 12.2025 (1 рік 9 місяців)
Робота над власним проєктом

Focused on completing my MA degree, including an Erasmus year at Aberystwyth University.

Complaints Manager

з 05.2021 по 04.2024 (3 роки)
Aktiia, Дистанційно (Медицина, охорона здоров'я, аптеки)

Swiss MedTech company developing a continuous, wearable blood-pressure-monitoring device.

Responsibilities:

- Managed medical-device complaint investigations from initial triage through investigation and closure, ensuring appropriate classification, documentation, escalation and follow-up in accordance with internal procedures.
- Acted as liaison between Customer Support and Core Tech teams during investigation of complex product issues, and supported the Quality & Regulatory team in audit preparation from a post-market surveillance perspective.
- Performed monthly quality monitoring of complaint-handling activities to ensure compliance with SOPs and procedures, evaluating case quality, documentation standards, and adherence to internal procedures.
- Performed trend analysis to identify recurring product issues and emerging patterns, working with cross-functional teams to support investigation and process improvement.
- Delivered training and guidance to support teams on complaint handling, vigilance requirements, and quality standards, and developed onboarding materials and knowledge-base content for the team.

Part-time translator

з 09.2020 по 05.2021 (9 місяців)
Lingvo-Ukraine Translation Agency, Київ (Послуги для населення та бізнесу)

- Provided written translations of documents and publications from Ukrainian into English and French, specializing in legal translation.
- Prepared documents for notarization, legalization, and apostille certification, ensuring compliance with legal and regulatory standards.

Освіта

Rennes 2 University

Celtic Languages, Інші країни
Вища, з 2023 по 2025 (2 роки)

A master's degree in Language Studies, including a year at the University of Aberystwyth, Wales (UK).

Maynooth University, Ireland

Celtic languages, literature and linguistics, Maynooth
Незакінчена вища, з 2022 по 2023 (1 рік)

I spent the final year of my undergraduate program at Maynooth University (Ireland), where I had a chance to study Irish language and literature.

University of Rennes 2

Celtic languages and literature (Breton and Irish), Rennes
Вища, з 2020 по 2023 (3 роки)

Kyiv National Linguistic Institute

French Language and Literature, Kyiv
Вища, з 2016 по 2020 (4 роки)

Додаткова освіта та сертифікати

Internship from 2019-2020.

Language certificate DELF B2 obtained in 2016.

Знання і навички

  • English
  • French
  • Translation
  • Freshdesk
  • NetSuite
  • Complaints management
  • Technical support for users
  • Customer Support
  • Staff training
  • Complaint Handling
  • Vigilance
  • Cross-functional collaboration
  • Process quality improvement
  • Post-Market Surveillance
  • Knowledge Management
  • Onboarding for staff
  • Training
  • Escalations management
  • Research skills
  • Product quality control
  • Employee training
  • Jira
  • Adobe Audition

Знання мов

  • Англійська — просунутий
  • Французька — просунутий
  • Українська — вільно

Рекомендації

  • Elisabet Crespi

    Elisabet Crespi

    Head of customer support, Hilo by Aktiia

    Контактні дані приховані
  • Kateryna Shatna

    Kateryna Shatna

    Customer success and operations, Swiss activities

    Контактні дані приховані
  • Roman Veremenkov

    Roman Veremenkov

    Internal Support Trainer, 3Shape Ukraine

    Контактні дані приховані

Додаткова інформація

My professional background spans Post-Market Surveillance, Complaint Handling, Vigilance, Technical Support, Training, and Knowledge Management in medical-device companies.

Over the past five years, I've worked with international teams in Switzerland and Denmark, closely collaborating with Quality, Regulatory, Product, Engineering and Customer Support. My work has involved complaint investigation, complaint coding, root-cause analysis, identifying and escalating potential vigilance cases, trend monitoring, and supporting audits from a post-market surveillance perspective. I've also conducted monthly quality reviews of complaint records to assess documentation quality and adherence to internal procedures and requirements in a regulated medical-device environment.

On the training and knowledge side, I've worked on onboarding and refresher training programmes, created study materials and knowledge resources, and maintained knowledge bases. I've also developed practical tools for customer support, including decision trees and structured troubleshooting guides.

I'm currently expanding my expertise in Quality & Regulatory Affairs through further training in EU MDR, ISO 13485, and ISO 14971. I'm interested in opportunities where I can build on my hands-on PMS and complaint-handling experience while developing further into Quality, Regulatory and vigilance activities.

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