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 nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at: www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

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