Senior RA Specialist

Senior RA Specialist
  • £45,000 per Annum
  • Permanent
  • Chester, Cheshire, England, UK Chester Cheshire UK CH4 9QZ
Job Ref: J2162800
Sector: Engineering
Sub-sectors: Biotech/Life Sciences, Medical Devices
Date Added: 25 November 2021
Here at SRG, we have an exciting opportunity for an experienced regulatory affairs professional to join an established aesthetic treatments company.

Their product portfolio spans from injectables to energy-based devices. They are looking for a Regulatory Affairs Senior Specialist to join their team in Chester.

As a Regulatory Affairs Senior Specialist, you will be responsible for all regulatory matters and requirements relevant to the company. You will be responsible for ensuring the company achieves agreed targets and schedules with the aim of maintaining current and obtaining new registrations related to company products. Some of your main responsible include but are not limited to the following:

  • To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in EU, US, Canada territories
  • Communicate to management any changes in regulations or requirements that have been identified
  • To undertake the preparation and submission of required regulatory applications (e.g., registrations, renewals, variations related to change controls and other identified changes to agreed timelines
  • To ensure all authorisations / registrations related to established products are maintained as required
  • Monitor pending submissions for timely approvals. Communicate to management any anticipated or identified delays that may impact the business
  • To interact with relevant consultants, regulatory and trade associations and other relevant third-party service providers to ensure their provision of any requested activities to agreed timescales
  • To provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities

As the ideal candidate, you will have at least 3-5 years' experience in regulatory affairs and knowledge of regulatory legislation and guidelines knowledge of EU, US, Canadian regulations. You will be educated in a scientific discipline, be organised, target-orientated, flexible and have good time management skills. It is desired that you have knowledge in dermatology/aesthetics and fluency in an additional language to English.

25/12/2021 16:33:22
GBP 45000.00 45000 Annum

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