Our client is a professional Healthcare and Medical Devices organization, based in Noord-Holland Netherlands.
My client is a manufacturer of high quality needles for medical purposes.
The rol is a interim position for a period of 4 monhts. This position provides the leadership role for the company in discussions with regulatory authorities in CE, US FDA, JPAL, Canadian regulations.
As a VP you will be in charge of the strategic manoeuvring the company in regulatory field. You will be responsible for the compliancy of the company with regulatory agencies (Canada, US, Japan, Europe) worldwide. Monthly reporting to the Management Team to inform the about the regulatory status or development of products. As the most experienced Quality Assurance and Regulatory Affairs professional in the company you will be in charge of training employee to get to the highest level of Quality Assurance and Regulatory Affairs within the company.
15+ years experience in Regulatory Affairs
Excellent track record for clearances worldwide
Experienced in US 510(k) fillings, JPAL, MDD, Canadian regulations
Good conceptual, analytical, solution minded and organizational skills
Good English, written and verbal
"can do" attitude
Bachelors degree in Life Sciences
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