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Career Opportunities

PHARMACEUTICAL REGULATORY AFFAIRS

Donawa Lifescience Consulting is seeking a regulatory affairs professional having at least five years' experience with European pharmaceutical marketing authorisations (centralised and national procedures), and obtaining scientific advice from the EMA or national competent authorities, to work on a part-time or project basis. Excellent English language skills and a willingness to travel are essential. Knowledge of medical device European and/or US regulatory requirements would also be an advantage.

MEDICAL DEVICE REGULATORY AFFAIRS

Donawa Lifescience Consulting is seeking a regulatory affairs professional having at least five years' practical experience with European CE marking and US market clearance (510k/PMA) requirements, to work initially on a part-time or project basis. Excellent English language skills and a willingness to travel are essential. Knowledge of EU/US quality system requirements would be an advantage.

CLINICAL RESEARCH ASSOCIATES IN EUROPE

Donawa Lifescience Consulting is seeking to expand its network of Clinical Research Associates (CRAs) based in various countries throughout Europe.

The services we are seeking from CRAs include:

• Regulatory and Ethics Committee submission support to sponsors for drug and medical device clinical studies
• Support for local contract negotiation
• Site monitoring and site management of clinical studies on medical devices and drugs
• Minimum qualifications and experience:
• B.S. in nursing or science field
• Previous monitoring experience for at least 2 years
• Previous experience in local Regulatory submissions
• Strong ability to work independently
• Fluent in English
• Willingness to travel

If you are interested in any of these opportunities, please send your curriculum vitae to contact@donawa.com.