Job Ref: 214155244

Date: 2021-07-08 11:55:54

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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, supporting 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, developing 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 will 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 will 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 will assist activities to achieve the standards of excellence as set out in the company’s clinical governance, quality, and environmental policies.

There is an opportunity for you to undertake formalised professional development qualifications.

Salary Circa £22,500 plus 25 days holiday per annum rising to 27 after 5 years’ service, Contributory Pension Scheme, Private Health Care, Life Assurance, Modern office facilities, Subsidised canteen, Free parking onsite.

Working hours are Monday to Friday 9am-5pm

Experience Required

* Demonstrable accuracy and attention to detail

* A willingness to develop knowledge & expertise in Clinical Governance, Quality Assurance & Regulatory Affairs

* 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

* Ability to demonstrate strong numerical skills

* Ability to maintain legible, accurate and timely records

* Ability to demonstrate a willingness to work as part of a team and embrace necessary change

* Knowledge of medical devices regulations and ISO13485 (desirable)

* Experience in Life Sciences or Scientific field (desirable)

* Quality and/or Regulatory experience from healthcare setting (desirable)

* Previous audit experience (desirable)

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