Regulatory and Compliance Manager

Regulatory and Compliance Manager
  • £45,000 - £55,000 per Annum
    ANNUM
  • Permanent
  • Leeds, West Yorkshire, England, UK LS14 6UF Leeds West Yorkshire UK LS14 6UF
Job Ref: J36543
Sector: Science
Sub-sector: Medical Devices
Date Added: 18 June 2020
Regulatory & Compliance Manager - Leeds - Medical Devices - £Competitive

Regulatory & Compliance Manager - Leeds - Medical Devices - £CompetitiveSRG are currently recruting for a Regulatory and Compliance Manager to join a small Medical Device company near Leeds on a permanent basis at a competitive salary, depending on experience. This is an important role within the company and will be working alongside the Senior Management team. You will have full responsibility of maintaining and a quality management system that ensures compliance with the Regulation (EU) 2017/745 (MDR) and in a manner that is proportionate to the risk of the type of device.RESPONSIBILITIES:* Be the subject matter expert on Regulation (EU) 2017/745 (MDR) * Lead the Regulation (EU) 2017/745 (MDR) transition - establish, document, and implement a quality management system that ensures compliance with the Regulation (EU) 2017/745 (MDR) * Follow MDR/ISO developments closely and develop, maintain, keep up to date and continually improve the quality management system.* Draw up and keep up to date the technical documentation and the EU declaration of conformity in accordance with the Regulation (EU) 2017/745 (MDR) requirements.* Implement, maintain, keep up to date and continually improve a post-market surveillance system in accordance with Regulation (EU) 2017/745 (MDR) requirements.* Establish, implement, and maintain a system for recording and reporting of incidents and field safety corrective actions accordance with to Regulation (EU) 2017/745 (MDR) requirements.* In the case of investigational devices - ensure that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation (performance study) and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient.* Conduct internal and support external MDR audits* Manage Notified Bodies or any other regulative inspections related to MDR* When required liaise with regulatory bodies - MHRA, EU Representative, etc* Perform internal MDR trainingThis is a stand alone role, working with the support of a Quality Administrator. It could suit someone in a Senior QA/RA role or somone who is in a 'hands on' management role.Permanent role, Mon - Fri with flexibility to WFH when it is appropriate to do so.For more information, please call Laith Mustafa on 0161 868 2231 or email laith.mustafa@srg.co.uk

SRGTalent
18/07/2020 16:31:09
GBP 45000 45000
Contact Consultant:
Laith Mustafa

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