Position Details

Position Title: Vice President, Regulatory Affairs
Location: Castle Rock, CO
Position #: 3020

Scope of Responsibility

Required to lead the regulatory function as follows:

• Develop the regulatory strategy for all diagnostic products in development
• Keep CEO apprised of all regulatory requirements and obligations
• Keep company apprised of all current and new regulations and any developing trends
• Responsible for preparing and spearheading all submissions to regulatory authorities
• Lead any interactions with regulatory consultants
• Oversee any regulatory requirements for marketed products

 

Qualifications

• Minimum 10 years experience with FDA regulations and submissions specifically for IVD’s - 510(k); de novo 510(k); PMA experience
• Experience with both the analytical and clinical aspects of IVD development
• Demonstrated success in partnering with QA/QC
• Demonstrated success in writing submissions and providing regulatory strategic guidance to senior management
• Familiarity with OIVD personnel
• Knowledge of European regulations, submissions and regulatory authorities, a plus.

 

 Compensation

• Base & Bonus        Commensurate with experience

• Stock Options         Yes (amount determined by CEO and BOD)

 

 Travel

• ~25%

 

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