Experience

MedGyn Products, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance & Regulatory Affairs Manager

  • Feb 2013 - Present

  Develop and implement regulatory strategies. Implement quality system regulatory procedures and initiatives into achieve compliance with ISO 13485:2016. EUMDR Gap analysis, MDR Project requirements and Implementation Maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality systems improvements, and business process improvement initiatives. Act as a Management Representative. Responsible for regulatory activities for domestic and international regions such as US, EU, Canada, Asia and South America and other markets for obtaining and maintaining regulatory filings and registrations for these regions. Responsible for the coordination and preparation of 510(k) document packages, EU Technical Files, Product Reports, and Supplements. Show less



NeilMed Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Sr.Regulatory Affairs Specialist

  • Oct 2008 - Dec 2012

  Formulate domestic and international regulatory strategies for various product lines. Provide regulatory perspective at project team meetings and design reviews. Identify and recommend new systems for improving Department efficiency and strategies for improving effectiveness of existing systems such as document management, filing, Regulatory submission prep, etc. Participate in FDA, TUV, Brazil Anvisa and ISO audits. Formulate domestic and international regulatory strategies for various product lines. Provide regulatory perspective at project team meetings and design reviews. Identify and recommend new systems for improving Department efficiency and strategies for improving effectiveness of existing systems such as document management, filing, Regulatory submission prep, etc. Participate in FDA, TUV, Brazil Anvisa and ISO audits.


Kemwell Biopharma
• India
• Biotechnology
• 300 - 400 Employee
• Executive - Quality Assurance & Regulatory Affairs

  • Mar 2005 - Aug 2008

Aurobindo Pharma
• Colombia
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Sr.Quality Assurance Executive

  • Mar 2004 - Mar 2005

GlaxoSmithKline
• United States
• Investment Management
• Manufacturing Executive

  • Jan 2002 - Mar 2004