Description
On behalf of our client, a well known company within the health care industry, I am currently recruiting a consultant for a Interim Medical Devices - Head of Quality and Regulatory position.Requirements for this position:
- At least Bachelor's degree in Engineering or a Life-science relevant area (further education/degree in quality or/and business management is a plus)
- Minimum 5-10 years of experience in a leading role within Quality & Regulatory Affairs
- Strong knowledge regarding medical devices quality systems including the necessary regulations (EU/US and Canada)
- Sound validation experience (process, equipment and software)
- Experience with standards and regulations of electronically devices
- Excellent communication and people management skills
- Customer orientated mindset
- Fluent English
Responsibilities including (not limited too):
- Continues improvement of the quality systems and processes
- Identify and closure of gaps
- Responsible for the regulatory strategy
- Preparation and execution of any kinds of Audits (internal, external)
- Complaint Handling / CAPA/ Product recall management
- Implementation of necessary activities and changes to ensure regulatory compliance
- Point of contact for notified bodies
If this position could be of interest for you or a person from you network, please send your CV in Word including your hourly rate expectation for immediate consideration.