GXpeople are supporting client who are Medtech company, specialising in respiratory consumables and patient monitoring equipment.
They are looking for a Regulatory Affairs Manager to oversee the QMS to ensure compliance with the applicable requirements of the essential requirements of the MDD 93/42/EEC and MDR (EU) 2017/745.
This candidate will be responsible for ensuring the ongoing compliance of the ranges of Class I medical devices, with particular focus on Clinical Evaluation Files, Post-Market Surveillance and Risk Management.
Main Responsibilities
• Managing a hands-on plan of action to audit and improve Technical Files,
• Documentation and implementation of improved procedures relating to technical file management, with specific emphasis on:
o Clinical Evaluation Files
o Post Market Surveillance
o Risk Management
• Ensuring compliance of devices to all applicable regulations.
• Drafting, maintenance and review of EC declarations of conformity
• Maintain registration of devices on applicable online databases
• Evaluating regulatory requirements for new markets and existing international distribution agreements (including FDA).
Qualifications & Experience
The following requirements should be supported by strong qualifications (preferably to degree level), or relevant working experience:
• Experience of working within the medical device industry is essential and knowledge of the current regulatory frameworks such as EU MDR, UK MDR & US FDA 21 CFR 820 is essential.
• Strong understanding of the requirements of ISO 13485:2016
• Experience drafting Clinical Evaluation Files in compliance
Please apply to this advert for more information.
Please not you must have perpetual right to work in the UK and this is a 100% on site position