Марія

Post-Market Surveillance Specialist, 128 000 UAH

Considering positions:
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
Employment type:
full-time, part-time
Age:
28 years
City of residence:
Other countries
Ready to work:
Remote

Contact information

The job seeker has provided: Phone numberEmailLinkedInMessenger

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Work experience

Self-employed

from 04.2026 to now (6 months)
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

from 12.2025 to 04.2026 (5 months)
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.

Career break

from 04.2024 to 12.2025 (1 year 9 months)
Working on a personal project

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

Complaints Manager

from 05.2021 to 04.2024 (3 years)
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

from 09.2020 to 05.2021 (9 months)
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.

Education

Rennes 2 University

Celtic Languages, Інші країни
Higher, from 2023 to 2025 (2 years)

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
Unfinished higher, from 2022 to 2023 (1 year)

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
Higher, from 2020 to 2023 (3 years)

Kyiv National Linguistic Institute

French Language and Literature, Kyiv
Higher, from 2016 to 2020 (4 years)

Additional education and certificates

Internship from 2019-2020.

Language certificate DELF B2 obtained in 2016.

Knowledge and skills

  • 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

Language proficiencies

  • English — advanced
  • French — advanced
  • Ukrainian — fluent

References

  • Elisabet Crespi

    Elisabet Crespi

    Head of customer support, Hilo by Aktiia

    Contact details are hidden
  • Kateryna Shatna

    Kateryna Shatna

    Customer success and operations, Swiss activities

    Contact details are hidden
  • Roman Veremenkov

    Roman Veremenkov

    Internal Support Trainer, 3Shape Ukraine

    Contact details are hidden

Additional information

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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