Regulatory Affairs Senior Associate

Regulatory Affairs Consultant - Medical Devices

Home based UK

12 month contract

£45 per hour maximum pay (inside IR35)

37.5 hours per week

Global Medical Device company

Summary

Support the management of CE marking activities (MDD 93/42/EEC and MDR 2017/745) and UKCA marking activities (UK Medical Device Regulations 2002) for medical devices from all Global Business Unites (GBUs), with emphasis on regulatory compliance and life cycle strategy.

Essential Duties and Responsibilities

• 
  Support the development/alignment of regulatory policies and strategies across all GBUs
  * Working with cross-functional groups to ensure the development of regulatory strategies for the CE and UKCA marking of new Medical Devices in accordance with the business goals.
  * Support development of strategic plans for submissions and authority interactions.
  * Participate in regional Industry Association meetings (including MedTech EU working groups).
  * Interpret existing, pending and proposed regulations/guidance documents regarding MDD, MDR and UKCA - providing assessment on impact.
  * Supports the Legal Manufacturer in its fulfilment of its regulatory responsibilities under the MDD, MDR and UKCA.
  * Support the implementation of the RA management systems (incl. relevant SOPs) to ensure the regulatory requirements of are met.
  * Support the maintenance and planning activities related to CE and UKCA marking of medical devices.
  * Provide direction to all Medical device legal manufacturers with regards to CE and UKCA marking of medical devices.
  * Support in CE and UKCA mark related regulatory activities in front of the Notified Bodies, UK Approved Bodies and relevant Competent Authorities.
  

Qualifications

• Degree in engineering or life sciences
  

Key Skills and Experience

* Around 3-5 years of experience in Medical Device Regulatory Affairs.
* Good knowledge of CE marking of medical devices. (MDD 93/42/EEC and related directives and guidelines).