SM
CofounderVerified
Sofia Marek
Health · Warsaw
Regulatory & ops lead (ex-Bayer) for healthtech builds.
Regulatory affairs and operations leader. I take healthtech products through MDR and into market.
“Give me a messy regulatory pathway and a technical team that ships — I will handle the rest.”
What they’re looking for
Target role
COO
Commitment
Full-time after 3-month notice
Equity
15–25% as third cofounder
Location
Warsaw / hybrid EU
Skills
RegulatoryOperationsMDR
Background
Director, Regulatory Affairs
Bayer
2019–2026
EU market access for two class-III devices.
Clinical Ops Manager
Bayer
2014–2019
Ran multi-site trials across 6 countries.
Regulatory Advisor (fractional)
Two seed healthtechs
2022–2026
CE-marking strategy; both cleared MDR audits first pass.
Education
Executive MBA
INSEAD
2020
PharmD
Medical University of Warsaw
2012
Sectors they want to build in
HealthTechMedTechDigital therapeutics
What they can invest
Sign in to see what they can put in.
PolishEnglishGerman
References
“Sofia took two class-III devices through EU market access on first submission — vanishingly rare.”
VP Regulatory Affairs, Bayer
At a glance
ex-Bayer
team
✓ Verified
6 MDR
approvals
✓ Verified
11 yrs
experience
✓ Verified
What's verified
IdentityVerified
Employment historyVerified
ReferencesAfter match
Investment capacitySelf-reported