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Global Regulatory Affairs Expert

  • Job type: Permanent
  • Location: Göttingen
  • Salary: Competitive
  • Job reference: BY-2018
  • Sector: EPM Scientific, Regulatory
  • Date posted: 16/02/2018

Global Regulatory Affairs Expert


A leading global provider for the biopharmaceutical industry is seeking a Global Regulatory Affairs Expert, required for in Goettingen, Germany. The RA Expert will be joining the Regulatory Affairs team, participating in project work regarding global medical device approvals.

Company Overview


The Company is a world-leading laboratory and pharmaceutical supplier, specialising in fermentation, cell cultivation, filtration, purification, fluid management and lab technologies. The company prides itself on supporting biopharma companies around the world to develop and produce drugs safely, timely and economically.

Responsibilities:


- Creation of a global process for the analysis of the requirements for the registration of medical devices and the creation of a global process to control the distribution of medical devices in the respective target markets
- Preparation and implementation of global medical device approvals
- Assistance with audits and inspections
- Cooperation in interdisciplinary and intercultural teams

Skills and Experience Required

- Completed science or technical studies
- 5 years or more of practical experience in medical device approval
- Reliable handling of the regulatory and normative requirements in the area of medical devices: management systems, risk management, biocompatibility, clinical evaluation (ISO 13485, Medical Device Directive / Medical Device Regulation, ISO 14971, ISO 10993, 21 CFR Part 820 QSR, etc.)
- Fluent English and German

How to 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.a33ho1gmasa@epmscientific.aptrack.co.uk or phone +442036678354

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