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TITLE - Quality Assurance / (QARA) Regulatory Affairs Manager Manager
PRODUCTS - Dental / Medical Devices
LOCATION - Kent
In this exciting QARA Management role, you will take be an integral part of the Operations team and will organise, plan, direct and control all Regulatory Affairs and Quality Management functions including product registration, complaint handling & reporting, internal and external quality audits. You will also serves as the Quality System Management Representative and Medical Device person responsible for Regulatory Affairs and will develop policies, procedures and training to ensure efficient operation of the company quality system and regulatory requirements.
Requirements
1. Degree educated or equivalent, in a life science or engineering discipline
2. A minimum of 5 years' experience in a medical device regulatory environment
3. An in-depth knowledge and appreciation of the regulatory requirements including technical files for placing class I & II medical devices on the European market. Experience in other markets (North America, Asia-Pacific markets) would be desirable.
4. Strong Knowledge of the Medical Device Directive (MDD) and Medical Device Regulations (MDR)
Apply now to find out more about this exciting role.
The role is covered in the following locations: Tonbridge
Role Overview
Are you an experienced Quality Control Manager / Specialist, with a strong medical device background? If so, Zenopa has the role for you.TITLE - Quality Assurance / (QARA) Regulatory Affairs Manager Manager
PRODUCTS - Dental / Medical Devices
LOCATION - Kent
In this exciting QARA Management role, you will take be an integral part of the Operations team and will organise, plan, direct and control all Regulatory Affairs and Quality Management functions including product registration, complaint handling & reporting, internal and external quality audits. You will also serves as the Quality System Management Representative and Medical Device person responsible for Regulatory Affairs and will develop policies, procedures and training to ensure efficient operation of the company quality system and regulatory requirements.
Requirements
1. Degree educated or equivalent, in a life science or engineering discipline
2. A minimum of 5 years' experience in a medical device regulatory environment
3. An in-depth knowledge and appreciation of the regulatory requirements including technical files for placing class I & II medical devices on the European market. Experience in other markets (North America, Asia-Pacific markets) would be desirable.
4. Strong Knowledge of the Medical Device Directive (MDD) and Medical Device Regulations (MDR)
Apply now to find out more about this exciting role.
Apply for this role
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