Regulatory Affairs Manager
Hourly rate: members only
Availability: members only
Willingness to travel: Not specified
Professional status: Freelancer
Last updated: Mar 25, 2026
Total work experience: 5 year(s)
Language skills: English, French, Russian,
Personal summary
I’m a Regulatory Affairs and Compliance Manager with 5+ years of experience guiding Software as a Medical Device company towards ISO 13485, ISO 27001, CMDR, and MDSAP compliance. At the intersection of quality, cybersecurity, and regulatory strategy, I specialize in ensuring audit readiness, process efficiency, and optimizing Quality Management Systems. I’ve led 5 successful External Audits (MDSAP, ISO 13485), prepared an FDA 510(k) submission, and developed dozens of Cybersecurity policies and Quality procedures to meet ever-evolving regulatory expectations.
Language skills
English
Native speaker
French
Advanced
Russian
Native speaker