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Senior Regulatory Affairs Expert

  • Job type: Permanent
  • Location: Munich
  • Salary: Competitive
  • Job reference: RNMR - 13203
  • Sector: EPM Scientific, Regulatory
  • Date posted: 08/01/2018
Senior Regulatory Affairs Expert

A global leader in the IVD biomedical testing field is seeking an experienced regulatory affairs person for their site in Munich, Germany. This senior regulatory affairs expert will join the informatics team within the regulatory affairs department and be involved with diagnostics, working with a multifunctional project team and collaborating with a number of other teams, they’ll be reporting to the Head of Quality and Regulatory Affairs. They will coordinate and execute all regulatory activities and strategies for the informatics devices, including CE-marking and FDA AND Canadian approvals, plus post-market activities.

Company Overview

The company is a global leader in the IVD industry, producing diagnostic instruments AND research instruments. They have over 200,000 staff globally and operate on every continent. It's a very multicultural environment, with English being the business language. This company is a market leader, they innovate and excel in their life sciences field, and they have been making a difference to people's lives with their products.

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 and multicultural 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.a33ho1gl609@epmscientific.aptrack.co.uk or phone +442037588934
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