Role: Regulatory Manager - Medical Devices - Work from home!
Location: Work from home / Fully remote
Salary: £40,000 - £42,000
We are looking to recruit a Regulatory Manager for one of our Household Clients who specialise in Cleaning Products and Medical Devices. This is a fully remote role with all equipment provided for the role. You will have RA experience within Medical Devices / ISO 13485.
Role:
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Person:
Knowledge/Experience/Technical Skills
- BSc or equivalent in a scientific discipline, medicine, pharmacy, law or engineering relevant to medical devices and at least one year of professional experience in regulatory affairs or quality assurance or, four years of professional experience in regulatory affairs or in quality management systems relating to Medical Devices (documented qualification).
- Proven knowledge, practical implementation and management of all regulations that affect the placing of Medical Devices on the market.
- Experience of undertaking Clinical evaluation, risk management (ISO14971) and post market surveillance activities.
- Knowledge of ISO13485.
- Proven track record of preparation and/or registering Medical Devices in UK/European and/or other international markets.
- Technical knowledge to be able to liaise effectively with chemists, microbiologists, and virologists.
- Good communication skills to translate complex regulations and scenarios to different audiences (interview).
- Working knowledge of regulations for Biocides.