10+ years medical device industry in variety of areas including Regulatory strategy for domestic and international marketing. FDA submissions of 510k and EU submissions of Technical Files for CE Mark. Implementation of Quality Systems per QSR, Health Canada, ISO 13485:2012, Medical Device Directive 93/42/EEC and Active Implantable Medical Device Directive 90/285.

Highlights:

• Quality Systems
• Medical Device
• Regulatory Affairs
• 510K submission
• CE Mark
• Consultant
• Director
• Vice President