Naukrijobs UK
Register
London Jobs
Manchester Jobs
Liverpool Jobs
Nottingham Jobs
Birmingham Jobs
Cambridge Jobs
Glasgow Jobs
Bristol Jobs
Wales Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Quality Assurance and Regulatory Manager

Adecco
Job LocationNottingham
EducationNot Mentioned
Salary£30,000 - £40,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

As the Quality Assurance and Regulatory Manager you will report directly into the Head of Operations. The primary focus of the role will be to lead and manage all aspects of the QA strategy and regulatory compliance function.Responsibilities Include:

  • Direct all aspects of the Quality Assurance and Regulatory Affairs functions, services and for medical devices and associated clinical lab activities
  • Responsible for the generation of regulatory submission documents and preparation of technical file documentation
  • Serve as the company points person to interact with notified Notified Bodies
  • Serve as the company representative during quality and regulatory audits
  • Develop and maintain internal awareness and knowledge of regulatory standards, ensure compliance of the internal quality system, and provide suitable interpretation to the company
  • Manage customer tracking as related to quality of products, complaints and post-market surveillance
  • Develop and implement programs for audits (internal, vendors) as well as the CAPA system
  • Promote a culture of compliance to regulations, standards and procedures and risk management throughout the organisation
  • Maintain an awareness of new and proposed legislation that impacts the business and communicate/implement as required.
    • Key Skills
  • Qualified Auditor
  • Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits e.g. NB audit
  • Ability to work cross-functionally
  • Excellent knowledge of the in vitro diagnostic industry including product development processes (ISO13485)
  • Ability to work independently while exercising good judgement and decision making within defined practices and policies.
  • Proficient in reading, analysing and interpreting scientific and technical information
  • Ability to demonstrate and convey high performance, high standards culture
  • Skills in MS Office packages (e.g. Excel, Word, Outlook, PowerPoint, Project)
    • To be considered for this position you must have a minimum of 5 years experience in QA ISO quality systems for IVDD (in-vitro diagnostics) and managing a quality system. Strong experience of ISO-13485, CE marking and a knowledge of IVDR.Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.By applying for this role your details will be submitted to Adecco. Our Candidate Privacy Information Statement explains how we will use your information - please copy and paste the following link in to your browser

    APPLY NOW

    Quality Assurance and Regulatory Manager Related Jobs

    © 2019 Naukrijobs All Rights Reserved