Michael Vader

Consultant, Global Regulatory Affairs, Quality Systems and Risk Management

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)

Global Leadership

Vision, Strategy and Direction
Strengthening Infrastructure
Building Culture/Mentoring
Negotiation/Consensus building
Capital Allocation/Financial Planning
Key Performance Indicators (KPI's)

Regulatory Affairs

510K Submissions
Premarket Approval's (PMA's)
CE Marking
US FDA 483 Warning Letters

​MDR's/Vigilance Reporting

Regulatory Compliance Strategies

“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


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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GLOBAL LEADERSHIP AND STRENGTHS






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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

Vision, Strategy and Direction
​Strengthening Infrastructure
Building Culture / Mentoring
Consensus Building / Negotiation
Capital Allocation / Financial Planning

Key Performance Indicator’s
Lean Manufacturing / Six Sigma
Regulatory / Quality Compliance
Product Development / Optimization
Risk Mitigation / Remediation​​​