Personal Information
Organization / Workplace
Greater Denver Area United States
Occupation
Director, Regulatory Affairs- InDevR, Inc.
Industry
Medical / Health Care / Pharmaceuticals
About
Proven exceptional performance in medical device development and design change through, provision of regulatory guidance for product classification, development, and clearance by domestic and international regulatory authorities.
Key Skills & Strengths:
Experienced in the coordination and management of submission activities for device clearance and/or approvals. This includes global registrations as well as US pre-sub, 510(k), PMA, IDE, and 10.75 Appeal submissions.
Well-developed listening, organizational, time, project, and resource management.
Excellent oral presentation skills.
Highly team oriented with recognized leadership, initiative, and communication strengths.
Expert k...
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