Clinical Governance, Quality Assurance and Regulatory Affairs Associate

Working within the Clinical Governance, Quality Assurance and Regulatory Affairs Team you will be involved in maintaining an effective documentation system supporting quality & regulatory standards within the business. This will involve ensuring the day-to-day management & co-ordination of technical documentation review and retention, undertaking collation of required reports at necessary timepoints, support technical query requests, along with supporting the initiation and maintenance of supplier assessment reviews. You will assist support and actively participate in the review and issue of Standard Operating Procedures (SOP) and associated documentation and develop the skills necessary for investigation and accurate documentation of customer complaints. You will actively contribute to and support the team in taking notes during meetings and participate with continuous improvement & development of the Clinical Governance & QARA department e.g., Corrective Action, Deviation, Change Control activities. You will be supported to develop skills necessary to conduct internal audits and assist in hosting audits by external regulatory bodies/customers. You will actively contribute & participate in Patient Reported Experience Measures (PREM) process & collation and will assist in maintaining a proactive quality culture throughout the organisation and assist activities to achieve the standards of excellence as set out in the company’s clinical governance, quality, and environmental policies. You must be able to take initiative, solve problems and deliver independently as well as working within a multi-disciplinary team environment. There is an opportunity for you to undertake formalised professional development qualifications.

You will behave in a professional manner at all times, and you will build professional relationships with customers that will enhance the Company’s quality image.

Essential:

  • Demonstrable accuracy and attention to detail
  • A willingness to develop knowledge & expertise in Clinical Governance, Quality Assurance & Regulatory Affairs
  • Possess good written & oral communication skills
  • Proven IT skills including Microsoft platforms e.g., TEAMS, Word, Excel, PowerPoint
  • Ability to build and maintain relationships with internal and external customers
  • Ability to prioritise, plan and organise workload and working to deadlines
  • Able to demonstrate strong numerical skills
  • Maintain legible, accurate and timely records
  • Ability to demonstrate a willingness to work as part of a team and embrace necessary change

Desirable:

  • Knowledge of medical devices regulations and ISO13485.
  • Experience in Life Sciences or Scientific field
  • Quality and/or Regulatory experience from healthcare setting
  • Previous audit experience

If you require any assistance or adjustments to be made when either applying for a position or attending interview, please e-mail us hr@clinimed.co.uk or give us a call on 01628 859726 and one of our team members will be happy to assist you.

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