A Regulatory Affairs - Technical File Specialist is required by established medical instrumentation design and manufacturer; to support and maintain the documented technical files for the company to MDD 93/42/EEC, MDR 2017/745 and MDSAP regulations.
* Experience in the Medical Device industry, working to BS EN ISO 13485:2016 Quality Management system, Medical Device Directive/Regulations and other regulatory jurisdictions.
* Ensure Technical/Design History Files are effectively maintained and comply with current MDD/MDR and MDSAP requirements, including but not limited to maintenance of Essential Requirements, Risk Management and Post Market Surveillance.
* Logical and practicable approach towards problem solving.
* Quality Risk Management principles to ISO 14971.
* Self-motivated but able to work as part of a team, including cross functional teamwork.
* Excellent communication skills with the ability to deal with people at all levels.
* Planning and facilitation skills with the ability to manage multiple projects simultaneously.
* Excellent IT skills with word and Excel.
* Attention to detail.
* Ability to communicate effectively both verbally and in writing.
* Must be able to manage stressful situations; firmly adhering to the principles of the regulations and guidelines.
* Good understanding of GMP & GDPR requirements.
* Supports all the organisations to achieve solution resolution.
* Maintain and co-ordinate risk assessments, Clinical review updates in line with Engineering change requests.
* Create data summaries for analysis and trend identification.
Salary Guide/Rate Equivalent to: circa £30-40k per annum
6 month assignment, possible extension
Location: Harlow, Essex
Please bear in mind that you may not hear from us straight away. Due to the high level of applications we receive every day, we can only respond to applicants whose skills and qualifications are suitable for this position.
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