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Role Filled

QA & RA Manager

Medical Devices & Equipment
Regulatory & Compliance
Medical Devices
Twickenham
£45,000 - £50,000
Woundcare (NP)

Role Overview

You will lead the QA and RA function to drive FDA approval of a novel medical device, working closely with the directors of a small but growing company. Your performance will be measured by your delivery of regulatory milestones, audit readiness, and QMS compliance.

Company Information

Zenopa have partnered with a UK-based medical device company specialising in cold plasma technology for infection control. Their CE-marked device, SteriPlas, supports wound healing and infection management without antibiotics. Their expert team ensures reliable solutions for healthcare providers.

Role Requirements

Manage, maintain and ensure compliance of the QMS to ISO13485, 21 CFR 820, and MDR
Plan and conduct internal audits across the organisation
Lead post-market surveillance activities and ensure proper documentation
Support MDR and FDA submissions and regulatory strategy for global markets
Review technical files, risk management documentation, and GSPR alignment

Person Specifications

University degree in life sciences, scientific or engineering discipline
Minimum 4 years’ experience in a regulatory and quality environment (MDD, MDR, FDA, ISO13485)
Experienced internal auditor with demonstrable knowledge of relevant regulatory frameworks
Fluent written and spoken English
Strong IT skills, including MS Office

Package

Bi-annual profit-sharing bonus
4-day working week (34 hours) with flexible hours
Private pension
Private health insurance

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

Egham
Richmond upon Thames
Staines
Twickenham
Previous Listing
Date Updated
01 May 2025
Job reference
74259
Categories
Full Time
Take Experience
This role has been filled
Hiring contacts
Kiera 3x4 2025
Kiera Allen
Expertise: Dental, Medical Devices
This role has been filled
Why Zenopa?

We aim to operate and maintain the following set of core values

Group people cartoon
01

We liaise on your behalf

Required equipment, e.g. cars, laptops, mobiles, we negotiate with the employer source and manage these on your behalf.

02

Solid Industry Relationships

Our recruitment teams have built relationships with some of the UK’s most prestigious pharmaceutical companies

03

High Success Rate

Our structured recruitment approach allows us to deliver consistently successful outcomes for both clients and candidates, supporting long-term placements and repeat partnerships.

04

Systems that work for you

As an ISO 9000 organisation we have fully defined systems that are regularly audited. You can be assured we consistently following processes that deliver for all.