RAQA Specialist (Medical Devices)

Hi, I am managing this position

Jack Lundgren

Senior Consultant

Sussex
Permanent
£30k - 40k per year
Science

A globally recognised Medical Device company based in Sussex are looking for a proven Regulatory Affairs Specialist on the permanent side of their business as they look to grow further in the industry.

The company are known for their excellent employee satisfaction and as a result have great retention rates across the board so this will be a role suitable for someone looking to settle in and grow as the company expands.

The Regulatory Affairs Specialist (RA) will be responsible for:

  • To support the day to day management and co-ordination of the technical documentation, including

Clinical Evaluation Reports, Technical Files and Risk Management as per the requirements of

ISO13485:2016 and applicable medical device regulations

  • To assist with Post-Market Surveillance, writing plans and reports and reviewing data from customers
  • To monitor changes in global medical device regulatory requirements
  • Provide regulatory guidance to other departments e.g. Sales and Marketing when needed including

assistance with regulatory submissions

  • To help conduct material safety and biological assessments in accordance with ISO10993
  • To support Research and Development teams by providing regulatory guidance to ensure compliance

 through all stages of new product development and entry into new markets

  • To assist in maintaining a proactive compliance culture throughout the organisation and assist quality

activities to achieve company KPIs

  • To participate in continuous improvement, corrective actions and business risk minimisation
  • To support audits by external regulatory bodies
  • To represent the Quality Assurance and Regulatory Affairs Department at internal meetings and

Training events

  • To undertake any internal/external training as required
  • To perform other duties as requested by Senior Management
  • Responsibility to adhere to the Company’s Health and Safety policy at all times and operate and

promote the development of quality standards and procedures taking ownership of tasks and to seek

new improved ways of doing things

 

In return, you will receive a salary between £30,000 and £40,000 and excellent development of your skillset. The Interview process will start this week with telephone interviews followed by a virtual interview final as the company are more than happy to hire remotely during this global pandemic.  

If this sounds like something you would be interested in then please apply now! If you want to discuss similar opportunities then email me at j.lundgren@x4lifesciences.co.uk

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