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Role Filled

Quality and Regulatory Manager

Medical Devices & Equipment
Regulatory & Compliance
QA/ RA
Bracknell
£50,000 - £55,000

Role Overview

You will support product registrations, document maintenance, and compliance activities, helping to manage a small team within the department.

Company Information

Join a well-established, family-owned business specializing in innovative home-use medical devices aimed at improving circulation and comfort. Operating globally, the company prides itself on a collaborative, easy-going culture with a highly educated workforce and a cash-strong financial position.

Role Requirements

Manage product registrations and maintain regulatory documentation.
Lead regulatory compliance including MDR, FDA, CAPA, QMS, and change control processes.
Oversee audits and risk management activities.
Support and manage a small team within the department.
Collaborate closely with commercial and cross-functional teams.

Person Specifications

Proven experience in medical devices QA and regulatory affairs.
Strong knowledge of MDR, EU and FDA regulations, and product registration processes.
Experience with project management and people management.
Familiarity with auditing, CAPA, QMS, and risk management.
Ability to commute to office location near Bracknell (hybrid working model).
Career longevity and commitment to the medical devices industry.
Immediate start preferred (no candidates with notice periods over 3 months).

Package

Pension after probation.
25 days annual leave plus public holidays.
Hybrid working arrangement (3 days in-office).
Supportive and social work environment with free parking and excellent local amenities.
No micromanagement – flexible and easy-going culture.

Even if you do not fit the criteria, we still want to hear from you! We have over 300 jobs not advertised on the website that you could be a perfect fit for!

Locations

Basingstoke
Bracknell
Newbury
Reading
Wokingham
Previous Listing
Date Updated
21 Aug 2025
Job reference
74927
Categories
Full Time
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