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Global Regulatory Affairs Manager

  • Job type: Permanent
  • Location: Munich
  • Salary: Competitive
  • Job reference: RNMR - 198333
  • Sector: EPM Scientific, Regulatory
  • Date posted: 20/02/2018
Global Regulatory Affairs Manager

A global Regulatory Affairs team is looking for an experienced Global Regulatory Affairs Manager for its location in Munich. This Global Regulatory Affairs Manager will join the regulatory affairs department and be involved in establishing the software and hardware implantable medical device supervisory team. They become part of a multi-functional project team that currently includes a Director of Quality Assurance and Regulatory Affairs, two senior Regulatory Affairs specialists and four Quality Specialists. You will report to the Director of Quality and Regulatory Affairs. The Global Regulatory Affairs Manager will coordinate and conduct all regulatory activities and strategies for the software and hardware medical devices. They will play an important role in the preparation and implementation of strategies for the MDR, including CE marking and FDA approvals, post-marketing activities, and continued growth of the RA team.

Company Overview

The company is headquartered in Munich but has locations worldwide (Singapore, China, Japan, Australia and the US). Their overall projected growth for the Munich supervisory team will increase from 7 to 15 within the next 18 months. Their impressive product pipeline has led to sales tripling in the last 7 years. They produce and sell devices that are important in both the diagnosis and treatment of a wide range of diseases, from orthopaedic diseases to cancers. Their devices range from class IIb-III.
Responsibilities: Develop and implement regulatory strategies for assigned projects / products Provision of regulatory support in the development process of software medical devices Provision of know-how in applicable regulations to identify and suggest possible strategies that can be used to address the gaps Manage regulatory issues projects/products, including the preparation and submission of correspondence and applications to regulators, Work with the software development team and the image analysis team to define the documentation strategy Support the implementation of device changes to assess regulatory impact. 

Requirements

Bachelor's degree or equivalent in natural sciences (biology, chemistry or physics) OR Dip. Ing (medical subject preferred)
Strong experience with regulatory requirements for medical devices
International registration of medical devices
Fluent German


Package

Competitive salary and company car
Working in the city centre of Munich
Strong projected growth within the position
Opportunity to improve the experience of regulatory affairs in foreign markets
Insight into state-of-the-art technologies for the successful treatment of disease

Apply

Apply here if you are interested in this possibility or if you would like a confidential discussion about your career opportunities:  apply.a33ho1gmf0l@epmscientific.aptrack.co.uk OR call +442037588934
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