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Greater Boston Area United States

Clinical and Regulatory Affairs Executive

Accomplished executive with over 20 years hands-on experience developing and implementing sound global clinical and regulatory strategies for Class II and Class III Medical Devices. Experience includes working for both established and early stage medical device companies. Results: • Implemented new QMS System and received ISO 13485 and CE Mark certification in 9 months for complex device (robot). • Initiated and developed long-term relationships with over 30 KOLs and investigators. • Successfully negotiated creative and aggressive regulatory strategies to FDA and EU Notified Bodies. • Authored successful Class II and Class III regulatory and clinical submissions. • Achieved first a...