QARA Administrator

QARA Administrator

Salary £28k- £30k per annum

Details

Job Summary:

The QARA Administrator supports the Quality Assurance (QA) and Regulatory Affairs (RA) functions to ensure the Planer's medical devices comply with applicable regulatory requirements (e.g., ISO 13485, MDR 2017/745, FDA 21 CFR 820). This role plays a key part in maintaining documentation, coordinating quality system activities, supporting regulatory submissions, and ensuring ongoing compliance across the business.

Key Responsibilities:

Quality Assurance:

Maintain and update the Quality Management System (QMS) in accordance with ISO 13485 and internal procedures.
Administer document control processes, ensuring timely revision, approval, and distribution of controlled documents.
Support CAPA, non-conformity (NC), complaint handling, and change control processes.
Assist with internal and external audits (Notified Bodies, FDA, suppliers).
Ensure training records are accurate, complete, and up to date.
Monitor calibration, equipment maintenance, and environmental controls as required.

Regulatory Affairs:

Assist in preparing documentation for the filing of regulatory submission.
Manage registration activities for products in various markets (MHRA, EUDAMED, etc.).
Support with keeping up to date with regulatory landscape changes by identifying and documenting gaps.

Qualifications and Experience:

Bachelor's degree in a relevant field (e.g., Quality Management, Engineering, or related discipline).
Experience in a regulated environment (preferably medical devices or pharmaceuticals).
Understanding of ISO 13485, EU MDR, and/or FDA QSR requirements.
Strong organisational and administrative skills.
Excellent attention to detail and accuracy.
Proficiency in MS Office (Word, Excel, Outlook, Teams).If you have the above skills and wish to be considered for this position or find out more details then please contact Joanna on (phone number removed) or submit your CV alternatively, apply to this advert!

Proactive also offer a referral scheme for successful applicants - if you know anyone that could be suited to this position then please contact Proactive with there details and if they are placed by Proactive you will receive £250. T&Cs apply

Proactive Global is committed to equality in the workplace and is an equal opportunity employer.

Proactive Global is committed to equality in the workplace and is an equal opportunity employer.
Proactive Global is acting as an Employment Business in relation to this vacancy.

Proactive Global is committed to equality in the workplace and is an equal opportunity employer.
Proactive Global is acting as an Employment Business in relation to this vacancy