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QA & RA Manager

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

Role Overview

This role is a great opportunity to take ownership of the QA/RA scope in the business, working closely with the directors to deliver FDA approval on a novel medical device over the next 6-12 months. Working for a small growing business will give you the autonomy and ownership of the role – delivering the project is critical to their scope and growth plans globally so it’s critical the person taking up the position is driven to succeed and committed to the overal vision of the business and product.

Company Information

Zenopa are really pleased to be partnered with a growing UK subsidary of a highly innovative, global, public listed company with over 30 years experience develop novel plasma focused products. This innovative company is the leader in treatment of chronic wounds through the use of cold plasma – they develop and manufacture their devices in the UK and are committed to the highest quality of product and service to their customers.

Role Requirements

MAIN DUTIES OF THE POST
QMS management – Management, maintenance, and compliance (ISO13485/21 CFR 820/MDR)
Management and planning of the internal audit programme and conducting internal audits.
Post-Market Surveillance activities
MDR, FDA planning and implementation and regulatory support for other regions
Review of Technical Files, Risk Management and GSPR.

Person Specifications

KEY COMPETENCIES REQUIRED:
Drive to succeed
Flexibility and Resilience
Quality objectives
Initiative
Attention to Detail
Communication, impact & influence

Person Spec:
University degree in relevant life science, scientific or engineering-based discipline

Skills:
– IT skills, MS Office, Internet & email
– Language skills – Fluent in writen & spoken English

Knowledge & Experience
– A minimum of 4 years working in an MDD/MDR /FDA Regulatory/ISO13485 environment
– Good understanding of EU MDD/MDR,FDA, ISO 13485 requirements and ability to communicate and provide training on these technical and regulatory documents
– Internal Auditor
– Experience of FDA submissions

Package

Competitive salary
plus bi-annual profit-sharing bonus
– 4 day working week (34 hours) with fully flexible working hours
– private pension
– private health insurance

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    Further Details/Cover Note

    Locations

    Egham
    Richmond upon Thames
    Staines
    Twickenham
    Date Updated
    19 Mar 2025
    Job reference
    74259
    Categories
    Full Time
    Take Experience
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    Why Zenopa?

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

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    01

    In house, contracting department.

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    02

    We liaise on your behalf

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

    03

    Solid Industry Relationships

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

    04

    High Success Rate

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    05

    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.