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Quality Assurance and Regulatory Manager

Adecco
Job LocationNottinghamshire
EducationNot Mentioned
Salary£35,000 - £40,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Are you a Quality Assurance and Regulatory Manager looking for a new opportunity Are you a qualified auditor and have experience of ISO 9001 and ISO 13485 Are you familiar with IVDD and IVDR If so, please read on.My client are looking for an experienced Quality Assurance and Regulatory Manager to lead and manage all aspects of the QA strategy and regulatory compliance function. As the Quality Assurance and Regulatory Manager you will report directly into the Head of Operations. This will cover both manufactured IVDs and services.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.Benefits

  • Very competitive salary - dependent on experience
  • 25+ bank holiday days
  • Auto enrolment pension
  • Free eye tests and flu jabs
  • Free parking available
  • Flexible working available
    • Key Responsibilities:
  • 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 organization
  • Maintain an awareness of new and proposed legislation that impacts the business and communicate/implement as required.
    • Key Skills
  • 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.
  • 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).
    • Shortlisting taking place this week, please apply today!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 explaining how we will use your information is available on our website.

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