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
Risk Management
IEC 60601 (3rd Edition)
IEC 62304/IEC 80002/IEC 82304
IEC 61010 (3rd Edition)
ISO 14971/ISO 24971
DFMEA/PFMEA/FMEA
Post-market Surveillance
Michael Brian Vader
Consultant, Global Regulatory Affairs, Quality Systems and Risk Management
Global Leadership
Vision, Strategy and Direction
Strengthening Infrastructure
Building Culture/Mentoring
Negotiation/Consensus building
Capital Allocation/Financial Planning
Key Performance Indicators (KPI's)
“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
Quality Systems
US FDA/GMP/GLP
ISO 9001/ISO 9004
ISO 13485/MDD 93/42/EEC
Audits (TUV, BSI, Intertek, PJR, UL)
Lean Manufacturing/Six Sigma
Validation and Verification (V&V)
Regulatory Affairs
510K Submissions
Premarket Approval's (PMA's)
CE MarkingUS FDA 483 Warning Letters
MDR's/Vigilance Reporting
Regulatory Compliance Strategies