Global submissions across 80+ countries
Oversaw international regulatory submissions and spearheaded China NMPA market entry, connecting regulatory strategy with business expansion.
ABOUT SYBEY
Clarity for your decisions.
Continuity for your project.
THE EXPERIENCE BEHIND SYBEY
Senior expertise.
Demonstrated impact.
SYBEY draws on more than 30 years of its founder’s experience in Quality, Regulatory and Clinical Affairs for high-risk Class III and IIb medical devices. This background combines executive leadership, PRRC responsibilities and hands-on delivery across EU MDR, US FDA and China NMPA requirements.
A track record built in demanding environments
Quality infrastructure that supported growth
Built a company-wide quality management system during growth from 40 to 400 employees, and later scaled compliance infrastructure as another organisation expanded from 38 to 260 employees.
Leadership across Quality, Regulatory and Clinical Affairs
Led a 30-person global department and served on an Executive Committee, aligning compliance priorities with commercial objectives and available resources.
EU MDR transition leadership
Directed the strategic transition to EU MDR 2017/745, coordinating quality, regulatory and clinical activities.
FDA inspection and integration experience
Successfully hosted consecutive FDA inspections and managed quality-system integration following an acquisition.
PRRC responsibilities and executive governance
Served as a PRRC and on executive and site management committees, bringing quality, regulatory and clinical priorities into leadership decisions.
YOUR NEXT CHALLENGE
That experience,
applied to your next challenge.
Through strategic advisory and fractional executive leadership, SYBEY helps MedTech manufacturers navigate market access, strengthen quality organisations and align clinical evidence with regulatory strategy. AI-assisted workflows offer an additional opportunity to improve operational efficiency, with expert oversight.
Class IIb & III · EU MDR · US FDA · China NMPA · MDSAP