Regulatory Affairs Specialist, Medical Devices, Saarland

Job Reference: #48524 Add to saved jobs

  • Location Saarland, Saarbrücken, Hesse, Darmstadt, Frankfurt
  • Permanent
  • Sector Medical Devices

Job Summary

Would you like the opportunity to work for an industry-leading medical device company? Given the changes to the regulations, this highly successful client is recruiting for a regulatory professional to update their technical documentation to meet MDR requirements. This is a great chance to get in with a multi-national company which offers great progression and benefits.

Job Overview

• Preparation and updating of regulatory / technical documentation for medical devices (list of essential requirements, medical device files, etc.)
• Creation and update of MDR regulatory documentation for medical devices
• Support for activities to maintain regulatory compliance (eg introduction of new regulations, product-relevant changes)
• Updating the risk management file for each product
• Support of Product Line Quality & RA in cross-site product quality monitoring activities (of the respective products)

Skills Required

• At least 3 years of experience in Regulatory Affairs or Quality in medical device industry
• Advanced knowledge of the relevant medical device regulations (MDD 93/42 / EEC, MDR 745/2017, NMPA regulation, MDSAP etc.)
• Advanced knowledge of applicable quality / risk management standards (eg ISO 13485, ISO 14971, ICH Q 10, EU GMP, FDA 21 CFR)

Contact Details

Please contact Nathan Berkley on +44203 019 6020 or email if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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