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Regulatory Affairs Director

  • Job type: Permanent
  • Location: Cologne
  • Salary: Competitive
  • Job reference: BY-2018-C
  • Sector: EPM Scientific, Regulatory
  • Date posted: 23/03/2018
Regulatory Affairs Director

An international leader in IVD software development is seeking a Regulatory Affairs Director for their site in Cologne, Germany. This Regulatory Affairs Director will lead the Quality and Regulatory department and oversee the building out of the regulatory affairs software team for oncological diagnostics, working with a multifunctional project team, currently including 5 regulatory affairs team members. The Regulatory Affairs Director will coordinate, implement and execute all regulatory activities and strategies for the software medical devices.

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
  • Coordinate the regulatory team in harmony with the software development team and the image analysis team to define documentation strategy
  • Provide expertise in applicable regulations in order to identify and suggest potential strategies that can be used to address the gaps
  • Direct regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies
  • 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, ISO14971, CFR Part 820
  • Experience leading people and projects
  • 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 Cologne
  • 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.a33ho1gnaf5@epmscientific.aptrack.co.uk or phone +442036678354


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