Director, Regulatory Affairs

Organization
D BASH Business Solutions LLC
Job Location
Madison, WI
Job Description

A rapidly growing, molecular diagnostic company in Madison, Wisconsin is looking for a Director of Regulatory Affairs.  The person in this position is responsible for leading the activities of the Regulatory Affairs (RA) team with emphasis on regulatory strategy and preparation, review, and submission of regulatory documentation for medical devices and in vitro diagnostics (IVD).

Location: Madison, WI

Responsibilities:

  • Identify and develop new regulatory policies, processes and SOPs
  • Provide current regulatory intelligence and formulate regulatory strategy
  • Oversee implemention of activities to secure regulatory approval of new products
  • Serve as principal interface with reviewers from FDA and other regulatory authorities
  • Supervise employee performance and develop career growth plan
Requirements

Desired Skills and Experience

  • Minimum education is Bachelor's degree in science, engineering, or medical field; MS or MBA is preferred; PhD in technical area or law is helpful but not required
  • 10+ years of experience in regulated industry
  • 8+ years of regulatory affairs experience in IVD/Medical device industry
  • Demonstrated ability to interpret and stay current with FDA and other regulatory agency regulations (e.g., EU)
  • Experience with eCTD requirements and electronic submissions
  • Demonstrated leadership experience
  • Excellent oral and written communication skills
  • Excellent organizational skills and attention to detail
How to Apply

Please send resume and cover letter to [email protected].

About Our Organization

D BASH Business Solutions LLC is a biotech recruiting firm in Wisconsin.  We are currently working with a growing, molecular diagnostics company.  For additional information about this or other openings in the biotech/pharma industry, see http://www.dbashsolutions.com.

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