Job Summary
A medical device research organization needs applicants for an opening for a Telecommute Quality Systems Principal Medical Research Manager.
Core Responsibilities of this position include:
- Acting as a lead during ISO audits and FDA inspections
- Developing and implementing strategies to assist clients with major audit deficiencies, including development of FDA 483 responses
- Managing at least 3 client projects concurrently
Position Requirements Include:
- Speak at conferences, webinars, or other marketing venues
- Demonstrated knowledge of ISO 13485, Good Manufacturing Practices (FDA QSR), EU Medical Device Directives
- Bachelor’s degree or equivalent experience in a related field, with a minimum of 10 years of relevant experience
- Project management experience
- Fluency in English and local language, if different, required
