Description
Qualifications: Experience in medical device regulatory affairs and quality assurance managing all aspects of regulatory and quality programs and submissions in the US and International countries. Excellent background in providing strategic direction and advice to project team members and company management regarding regulatory pathways, quality planning and timeliness for new and changed products and processes. Familiar with Food and Drug Administration Quality Systems, UDI Rule and GS-1 systems, International Medical Device Directive regulations and Health Canada Licensing requirements, submitted Premarket Authorization Supplements, 510 (k) Clearances, CE Mark Technical Files, Dossiers and Health Canada submissions.
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| Planet Pharma | Sr Regulatory Compliance Consultant | 1/2016 - 1/2017 |
| Staar Surgical | Director Of Regulatory Affairs | 1/2009 - 1/2016 |
| Nihon Kohden America Inc. | Director Of Regulatory Affairs And Quality Assurance | 1/2006 - 1/2009 |
| Quantimetrix Corporation | Director Of Operations, Regulatory Affairs And Quality Assurance | 1/2003 - 1/2006 |
| Iso 13485:2003 & Iso 9001 (Certified) | Rab Lead Auditor (Certified) | 1/2003 - 1/2003 |
Accomplishments
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