Senior Manager International Regulatory Affairs EMEA

Job Reference: #9344 Add to saved jobs

  • Salary £60000 - 70000
  • Location South, south west, cambridge, oxford, london, east anglia
  • Permanent
  • Sector Medical Devices

Job Summary

My client is an industry leading DNA sequencing business that is now looking for a Senior International Regulatory Affairs Manager to join their growing and innovative team. They are now building a robust Quality and Regulatory Affairs (RA) function in EMEA to streamline the registration and approval of IVD, Medical Devices and platform technologies.

Job Overview

• Professional colleague interaction at non-EU based business lines to support CE registration of products.
• Interaction with National Competent Authorities within any of the 28 EU member states and the 3 additional members in the EEA in connection with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC for product registration / notification and Medical Device Vigilance.
• Product registrations of both Medical Device products and IVD products in accordance to the IVDD and MDD.
• Ensures that the notification system is always up to date and in line with corporate policies and procedures.
• Responsible for organizing payment of notification fees to UK Authorities.
• Interaction with the non-European Union based business lines to ensure optimization of notifications made with the UK Authorities (MHRA).
• Co-ordinates all the details of notification in the European Union to support product launches.
• Some Travel within Europe as required & Eventual supervision of a small team of professionals (EU Authorized Representative Assistant/s)

Skills Required

• Strong experience of registering IVD & Medical Device Products.
• Proven Regulatory Affairs background in a Regulated industry
• Previous experience working with regulatory Authorities within the EMEA region
• Previous experience of DNA sequencing would be advantageous but not necessary

Contact Details

Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 019 5972. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.

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

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

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