Head of Quality & Regulatory Affairs


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

11th October 2022

Location

Ely

Salary/Rate

£70000 - £90000

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

Our client is a fast growing medical device manufacturer. The Head of Quality & Regulatory Affairs will lead the development and implementation of the Quality Assurance (QA) & Regulatory Affairs (RA) Strategy compliant with all relevant regulatory bodies, standards and directives and contributes to the overall delivery of company strategic objectives.Responsibilities:Lead the development and implementation of the QA and RA strategy compliant with all relevant standards (ISO9001, ISO13485, MDSAP, REACH) and directives in conjunction with the QA and RA department managers/supervisorsFulfil the requirements of the site quality management representativeMaintain current knowledge of Medical Device or IVD industry developments and regulations, clinical digital software and laboratory testing services and make recommendations regarding any changing requirements to the Operations DirectorThe Head of Quality & Regulatory Affairs will lead, plan and manage the internal and external audit programme to meet the required standards and schedulesLead, plan and manage the quality training programmes to meet the requirements of the quality management system and audit programmeLead, plan and manage the Validation Master Plan (VMP) to meet the requirements of the quality management system and audit programmeDirect, plan and manage clinical studies, regulatory submissions and other activities to facilitate the registration and pre-market notificationsLead, plan and manage Direct Country Specific registrations, Technical Files and Labelling activities to meet the requirements of the relevant regulatory authorities The Head of Quality & Regulatory Affairs will demonstrate effective leadership for the QA/RA department and teamCreate a positive working environment in the department that facilitates employee engagement and a culture of high performance and continuous improvement Monitor QA/ RA department KPI's and implement strategies and processes as required to meet agreed targetsCollaborate with all departments regarding new product development and associated procedures and with commercial team regarding customer requirementsDevelop and maintain productive and professional relationships with colleagues, customers and other third partiesPeople Management: Lead by example and demonstrate consistent, good HR practice and people managementMotivate direct reports to achieve their potential through PDR's, regular 1:1's and training or developmentSkills/Qualifications: Maintain compliance with Health & Safety policies and proceduresMaintain compliance with QMS policies and proceduresMaintain compliance with GDPR and Cyber Security policies and proceduresIdeally degree level education or work experience commensurate with the position To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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