Michael Vader


"Consultant, Global Regulatory Affairs, Quality Systems and Risk Management"

EXECUTIVE PROFILE

Experienced and highly effective business executive with a proven track record of success leading all aspects of global regulatory affairs, quality systems and risk management for small start-up, mid-sized and large matrix managed private and publicly held Medical Device, Bio-pharmaceutical and In-Vitro Diagnostic (IVD) companies.
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EXPERTISE, STRENGTHS AND SKILLS

  • Corporate Regulatory Affairs, Regulatory Compliance and Quality Systems Leadership
  • Multiple Site Regulatory Affairs, Regulatory Compliance and Quality Systems Leadership
  • Quality System Design, Implementation and Regulation Compliance
  • Regulatory Agency and Notified Body Interaction and Negotiation 
  • Global Regulatory Affairs, Regulatory Compliance and Quality Systems Requirements 
  • Global Risk Management, Risk Mitigation and Risk Remediation Leadership
  • Business Leadership and Process Improvement 
  • Strategic Planning and Tactical Execution
  • Staff Development and Mentoring  


 

“Building my personal brand is one of the most important aspects of my business acumen; it affords me the opportunity to illustrate my background as a strategic business leader who represents true continuous improvement”. – Michael Vader