The People Who Make It Happen

Yvonne Middlefell

Medical Devices, Executive Director Regulatory Affairs

• [email protected]
• +44 (0) 1143 600868

A highly experienced regulatory professional with more than 20 years experience in Global Regulatory Affairs and R&D. In depth, hands on knowledge across a broad range of disciplines. Medical Devices, IVD’s, Biologics, OTC, Pharmaceuticals. Regulatory Affairs Certified USA.

Written and submitted over 30 510(k) submissions, PMA’ s, IDE’s. BLA’s. Worked in the USA for 10.5 years. France 1 year. Established RA functions for multinational organization including a start up company.

Experienced at board level and developing key global business and RA strategies.

Managed transnational teams. Actively engaged in external environment/RA Intelligence/RA Training.

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