Director of Quality Management Regulatory Affairs
Job Requirements
- Take responsibility for managing and planning all regulatory activities for assigned development program
- Help in defining the company`s global regulatory strategy
- Support the preparation of marketing authorisation Internationally
- Responsible for developing target product areas
- Organise and lead meetings with Health Authorities
- Review and examine Health Authority guidelines and competitor information
- Develop regulatory project targets
- Support and manage regulatory activities related to life cycle management
- Setup Quality Management System with regards to the regulatory process.
Skills Required
- Knowledge of international regulations relating to the development and approval of Medical Devices
- Fluent in English and German
- Experience of leading a team
- Ability to be very well organised and work well under pressure
Why you should apply
- The chance to build out your own team
- Direct report to CEO of Global organisation
- Flexible working hours and home office available
- Competitive Salary
- Chance to travel
- Great company benefits