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Manager Regulatory Affairs (Head of Department)

  • Job type: Permanent
  • Location: Freiburg ( Elbe)
  • Salary: -
  • Job reference: RA Manager/Head
  • Sector: EPM Scientific, Regulatory
  • Date posted: 06/07/2017
My client is an electronics company that has been developing and manufacturing high-tech and innovative medical technology and industrial equipment for more than 25 years. Their products are marketed worldwide in a future-proof market. 

Your duties include:
  • Maintain national and international approvals
  • Close cooperation with other departments in the company
  • Internal contact for relevant standards
  • Communication with the necessary authorities
  • Ensure compliance with the legal requirements of Directive 93/42 / EEC
  • National and international product approvals
  • Complaint handling (investigation of complaints, notifications to the authorities)
  • Coordination of authorizations (510 (k) / FDA general / Canada / EU)
Your profile:
  • Successfully completed technical studies or comparable training
  • Completed medical or natural sciences studies
  • Professional experience in the field of Regulatory Affairs in Medical Technology
  • Knowledge of standards, laws and regulations of medical technology (ISO 13485, ISO 9001, Directive 93/42 / EEC, MPG,
  • Very good communication ability
  • Proficient in German and English
  • Experience with risk management and approval procedures in medical technology
If you think this regulatory affairs manager/ head of department opportunity is something that you might be interested in, then please get in touch by telephone or email, or on my LinkedIn account.

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