09/04/2026 updated
100 % available
Quality & Regulatory Affairs Leader | QMS, GxP, ISO 13485, RWE, GDPR | Pharma, CRO & MedTech
Tallinn, Estonia
Only remote
MSc Biopharmaceuticals, King's College LondonAbout me
I help pharma, CRO and MedTech/SaMD companies design, implement and scale Quality and Regulatory systems. I have 13 years of experience across pharma, CRO and digital health, including Pfizer, AstraZeneca, IQVIA and two scale-ups.
ComplianceISO 13485Quality ManagementRegulatory AffairsGXP
Quality Management Systems (QMS)
Design, implementation, integration and audit of quality management systems according to ISO 13485, ISO 9001, ISO 42001 and GxP standards across pharma, CRO and digital health organizations. Experience also includes risk management, process redesign, implementation of new QMS tools, quality strategy and quality maturity assessment.
EU Medical Device Regulation & Regulatory Affairs
Expertise in EU MDR, PRRC responsibilities, technical file preparation and post-market compliance.
GDPR & Data Protection (DPO)
Assessment of company compliance against GDPR requirements, development and implementation of data protection policies, staff training and regulatory documentation. Experience serving as Data Protection Officer (DPO) and leading company-wide GDPR implementation programs.
CAPA and Audit Management
CAPA management and internal, external and client audits. Represented the Quality function in client audits and RFP qualifications, defending processes directly to auditors.
Experience
Professional experience10+ years
Freelancer since2020
Languages
EnglishFluentRussianNative speaker
Project history
Implemented global Quality strategy across 40+ international teams, standardizing compliance processes in a matrixed organization. Built and rolled out a compliance reporting and escalation process. Rebuilt a Quality Maturity Assessment framework to score teams against defined criteria, improving onboarding and risk identification.
Led Quality and Regulatory activities for a digital health company, advising team and management on compliance and regulatory requirements. Supported design and implementation of an ISO 13485 QMS, including processes and tools. Contributed to EU MDD Class I product certification, preparing the technical file and regulatory submission. Performed the initial GDPR gap assessment, then built the processes, policies, staff training and regulatory documentation required for market readiness. Acted as PRRC for post-market product compliance and a DPO.
Integrated the quality management systems of 5 acquired companies into the global RWE framework, covering process, tool and documentation alignment. Developed the QMS Acquisition Integration Tool, subsequently adopted by IQVIA's global M&A function. Integration were recognized as the most controlled and best-documented integration in RWE.