Job Title:
Senior Regulatory Affairs and QA Specialist - Medical Devices
Location:
Corsham, Wiltshire - 100% Office Based
Salary:
circa £50,000, negotiable depending on experience
Hours of Work:
Monday to Friday, 8.30am to 5pm
Holiday & Benefits:
25 days plus bank holidays, company pension scheme.
The Role
We are seeking a
Senior Regulatory Affairs & Quality Assurance Specialist
with experience in the medica device industry, to support an established Quality and Regulatory team in maintaining compliance with relevant medical device and IVD standards and regulations.
In this role, you will help to lead the team with activities to ensure continued certification and compliance, monitor and advise on the performance of the Quality Management System (QMS), and produce reports on performance against key indicators. You will play a key part in driving continuous improvement initiatives and promoting a strong quality culture throughout the organisation.
Key Responsibilities
* Lead the implementation, maintenance, and improvement of the Quality Management System in accordance with applicable standards and regulations.
* Monitor and report on quality performance, including tracking and trending key performance indicators (KPIs).
* Contribute to regulatory submissions, technical documentation, and product registrations.
* Provide guidance on compliance with EU MDR and IVDR requirements, as well as other international regulations.
* Support internal and external audits and ensure timely resolution of findings.
* Drive problem solving and continuous improvement initiatives across departments.
* Support Quality Improvement and Master Plans for the site.
Qualifications and Experience
* Bachelor's degree in a relevant discipline (e.g., Biomedical Engineering, Life Sciences, Regulatory Affairs, or similar).
* Minimum of 2 years' experience in a Senior Quality Assurance & Regulatory Affairs position within the medical device industry.
* Strong working knowledge of domestic and international medical device standards and regulations, including EU MDR and IVDR.
* Excellent written and verbal communication skills.
* Strong analytical, problem solving, and critical thinking abilities.
* High attention to detail and organisational skills.
* Ability to collaborate effectively within cross functional teams.
Closing date 25 th March 2026
Hawk 3 Talent Solutions are operating as an employment agency on behalf of its client.
To apply please follow the application process for the site this job is advertised on or mail your CV to
craig.-3.com
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Hawk 3 Talent Solutions are committed to the selection, recruitment, and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future.