Regulatory Affairs Manager - East Midlands
£55,000 - £60,000 +BONUS +CAR
A great career opportunity has arisen for a RA Manager to come and join a highly successful Medical Devices organisation. This position is for a new challenging talent that can develop and maintain worldwide regulatory knowledge. This is an excellent opportunity for an experienced specialist with the ambition and ability to achieve excellent results in a highly demanding industry and to find novel and radical solutions to new and existing problems under tough commercial, technical and time constraints
The position holder will principally be responsible for compliance with all prevailing RA Standards particular CE including technical files, certification and all other important documentation for devices. You will be the main point of contact with the MHRA, Trading standards and all other UK and Global agencies to unsure that compliance it met with all regulated standards. You will also be the main responsible person in the testing and fit for purpose analysis of all new and existing medical products to ensure that conformity to international standards and technical specifications
You will also be responsible for investigating and reporting product failures including advising on the appropriate RA pathway and risk management programmes and health and safety. They will be expected to advise/act on implications of new or amended standards relevant to the medical devices manufactured at the organisation. The person will be responsible for maintaining companies' device listing and establishment registration with FDA. Input may also be required on RA labelling requirements. Maintain Notified Body Approval for Class II medical devices.
To meet the requirements for this position you must have extensive experience in Regulatory Affairs within the medical devices sector. Good working knowledge of ISO 13485, Compliance
MDD, Quality Management Systems, strong experience working with Regulatory and statutory organisations, qualified or working toward NEBOSH certification would be an advantage. You must be conversant with ethical trading and experience of Quality Assurance.
If successful, you will be rewarded with a completive salary, Bonus, excellent benefits package, including car allowance, great bonus, private healthcare and dental care, a company pension scheme and an employee share purchase scheme. If you want to be a part of this exciting, challenging opportunity, please contact Ekta Multani, Medical Devices Recruitment Consultant at Paramount Recruitment, on 0121 616 3474 or ekta.multani@paramountrecruitment.co.uk
Keywords: Regulatory Affairs, Quality Assurance, Health and Safety, , Compliance, ISO 13485, ISO 9001, NEBOSH, MHRA, Quality Managing Systems, MDD, QMS, Class II, Medical Devices ,GDP, CE Marking, GDP, Risk Managment, Risk Assessment, EC Directive, 93/42EEC, Lean
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
£55,000 - £60,000 +BONUS +CAR
A great career opportunity has arisen for a RA Manager to come and join a highly successful Medical Devices organisation. This position is for a new challenging talent that can develop and maintain worldwide regulatory knowledge. This is an excellent opportunity for an experienced specialist with the ambition and ability to achieve excellent results in a highly demanding industry and to find novel and radical solutions to new and existing problems under tough commercial, technical and time constraints
The position holder will principally be responsible for compliance with all prevailing RA Standards particular CE including technical files, certification and all other important documentation for devices. You will be the main point of contact with the MHRA, Trading standards and all other UK and Global agencies to unsure that compliance it met with all regulated standards. You will also be the main responsible person in the testing and fit for purpose analysis of all new and existing medical products to ensure that conformity to international standards and technical specifications
You will also be responsible for investigating and reporting product failures including advising on the appropriate RA pathway and risk management programmes and health and safety. They will be expected to advise/act on implications of new or amended standards relevant to the medical devices manufactured at the organisation. The person will be responsible for maintaining companies' device listing and establishment registration with FDA. Input may also be required on RA labelling requirements. Maintain Notified Body Approval for Class II medical devices.
To meet the requirements for this position you must have extensive experience in Regulatory Affairs within the medical devices sector. Good working knowledge of ISO 13485, Compliance
MDD, Quality Management Systems, strong experience working with Regulatory and statutory organisations, qualified or working toward NEBOSH certification would be an advantage. You must be conversant with ethical trading and experience of Quality Assurance.
If successful, you will be rewarded with a completive salary, Bonus, excellent benefits package, including car allowance, great bonus, private healthcare and dental care, a company pension scheme and an employee share purchase scheme. If you want to be a part of this exciting, challenging opportunity, please contact Ekta Multani, Medical Devices Recruitment Consultant at Paramount Recruitment, on 0121 616 3474 or ekta.multani@paramountrecruitment.co.uk
Keywords: Regulatory Affairs, Quality Assurance, Health and Safety, , Compliance, ISO 13485, ISO 9001, NEBOSH, MHRA, Quality Managing Systems, MDD, QMS, Class II, Medical Devices ,GDP, CE Marking, GDP, Risk Managment, Risk Assessment, EC Directive, 93/42EEC, Lean
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
