12+ years navigating complex regulatory landscapes for medical device and IVD companies across Europe, CIS, and global markets.
Engage My ServicesFrom submission strategy to QMS maintenance, I provide end-to-end regulatory and quality assurance support tailored to your device class, target markets, and business timeline.
Acting as your Person Responsible for Regulatory Compliance under EU MDR/IVDR. I ensure continuous product conformity, maintain required documentation, and serve as the accountable expert before regulatory authorities throughout your device lifecycle.
Building clear, actionable regulatory roadmaps for markets/ regions including but limited by EU, CIS/EAEU, CEE, MENA, UK, and US markets. From market selection to approval pathways and submission sequencing — translating regulatory complexity into strategic advantage.
End-to-end creation and maintenance of Technical Files, CERs/PERs, PMS plans and reports, risk management files per ISO 14971, and GSPR checklists. Submission-ready documentation that satisfies notified body scrutiny across Class I through Class III.
ISO 13485 system implementation, maintenance, and improvement. I support internal audits, prepare organizations for notified body inspections, manage CAPAs, handle nonconformities, and drive continuous improvement — keeping your QMS compliant and effective. I lead external audits for your Suppliers and manufacturing sites/contractors.
Every market has its own regulatory DNA. I bring first-hand submission and management experience across major regulatory regions — not theoretical knowledge, but operational expertise from real submissions and approvals.
I don't just advise — I build, write, and manage. From strategy to submission documents to audit responses, I deliver complete regulatory work product.
Available for ongoing contracts or project-based mandates. Fully remote-capable with proven experience working across time zones and multicultural environments.
Having worked inside J&J, Smith+Nephew, and Fujifilm, I bring enterprise-level regulatory discipline to companies of any size.
I can formally assume PRRC duties under Article 15 of EU MDR/IVDR, providing your company with a legally compliant responsible person for the EU market.
Class I through Class III medical devices and IVD Class A–B — active implantables to in vitro diagnostics, the full risk spectrum.
Fluent in Russian and English, with basic Serbian, German, and Spanish. Comfortable engaging authorities, notified bodies, and international teams.
Whether you need PRRC coverage, a regulatory strategy for a new market, submission documentation, or QMS audit support — I'm available for direct conversation.
I work with startups entering the EU market for the first time, established manufacturers navigating MDR/IVDR transitions, and global companies needing regional expertise.
Typical engagements: PRRC contracts, Technical Documentation creation, QMS audits, regulatory strategy workshops, submission support.
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