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Regulatory Manager - MDD/ MDR

  • Job type: Permanent
  • Location: London
  • Salary: Negotiable
  • Job reference: 411503/001_1552481791
  • Sector: EPM Scientific, Regulatory
  • Date posted: 13/03/2019

Regulatory Manager - MDD

Job type: Permanent

Location: Home Based

Salary: Highly competitive

A leading global Medical Device Notified Body is currently seeking to hire a Regulatory Manager - MDD to ensure the Notified Body Medical has a robust, LEAN and user-friendly Quality Management System (QMS), Training and Competency in place for all staff globally and regulatory matters in compliance with the relevant requirements including:

Key responsibilities of the Regulatory Manager - MDD include:

  • Responsible for the development of implementation of procedures and policies for the operation of the notified body, where assignment of activities and responsibilities to personnel is clearly outlined including assessment and decision-making processes

  • Owner of the Notified Body Medical processes including Quality Manual, Non-Conformity and CAPA handling, Audit and Inspections, Training and Competency, Handling disputes / complaints / appeals, Document Control, Records, control, Regulatory Intelligence, Internal Audits and Quality Management Review

  • Make decisions related to the Notified Body QMS

  • Contact Person to hold the interaction with the authority responsible for the NB and the obligations regarding communications with other competent authorities, the Commission and other NBs

  • Responsible for informing notified body personnel of any relevant standardisation activities, relevant legislation, guidance and best practice documents including activities of relevant notified body coordination groups and vigilances

Key requirements of the Regulatory Manager - MDD include:

  • The role holder should possess either an appropriate degree, college degree or other qualifications and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors

  • Experience in Quality Assurance and Management on a global or multi-site scale

  • Experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry

  • Notified body experience, specifically in Conformity Assessments (e.g. Lead Auditor, Certification Authority, TD Assessor or similar)

  • Excellent knowledge the EU Medical Device Directive

If you are interested in the Regulatory Manager - MDD position, apply online today or contact Jamie Remp at +44 203 758 8975 for more information

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