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QA & RA Manager
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
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Locations
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