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Global Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Munich
  • Salary: Competitive
  • Job reference: RA 1373
  • Sector: EPM Scientific, Regulatory
  • Date posted: 29/11/2017
Global Regulatory Affairs Manager

An international leader in IVD software development is seeking an experienced Global Regulatory Affairs Manager for their site in Munich, Germany. This Global Regulatory Affairs Manager will join the regulatory affairs department and be involved in the building out of the software team for oncological diagnostics, working with a multifunctional project team, currently including 1 QA/RA head and 4 QA/RA specialists – they’ll be reporting to the Head of Quality and Regulatory Affairs. The Global Regulatory Affairs Manager will coordinate and execute all regulatory activities and strategies for the software devices, including CE-marking and FDA approvals, post-market activities and the growth of the RA team.

Company Overview

The company is a respected member of the software diagnostic device world, specialising in delivering innovative solutions that integrate tissue diagnostics with software, whilst also offering client consultation services. The company prides itself on the quality of their software, and their engaged culture, which stems from their passion for helping diagnose and ultimately defeat cancer.

Responsibilities:
  • Develop and implement Regulatory Strategies for assigned projects/products
  • Provide regulatory support in the development process of software medical devices
  • Provide expertise in applicable regulations in order to identify and suggest potential strategies that can be used to address the gaps
  • Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies
  • Work together with the software development team and the image analysis team to define documentation strategy
  • Support implementation of device change in order to assess regulatory implications
 

Requirements:
  • Bachelor’s degree in physical/biological sciences or engineering preferred
  • Expertise in standards and regulations for medical devices as ISO 13485, IEC 62304, IEC 62366, ISO 14971, CFR Part 820
    • Experience with Regulatory Affairs for medical device AND/OR IVD software
    • Strong written and verbal English communication skills
 

Package:
  • Competitive benefits and great personal development opportunities
  • Work in the city centre of Munich
  • Great atmosphere within a vibrant international team
  • A modern and creative working environment
  • Insight into cutting-edge technologies for the successful development of cancer therapies
 

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: apply.a33ho1gk8sb@epmscientific.aptrack.co.uk or phone +442037588934
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