SRG are currently looking for a QARA Manager/ Specialist for a Medtech client based in Bath. This company is leading the way in terms of how we carry out at surgical procedures and the equipment we use.
Ideally you will have 5+ years in in handling medical device quality and regulatory affairs from product design to market and beyond.
You will contribute to the development of new products, drive improvements in the company's standards and maintain regulatory accreditations. Your role will be vital to driving the company forward throughout new products and markets expansion into USA & Canada.
The ideal candidate will also have experience / knowledge in SaMD validation and familiarity with software regulations in line with new MDR and relevant standards. You will help with the application for and maintain approval of ISO, CE, MDR standards. Lead Internal /external audit, CAPA process
You will also look after the preparation for IEC approval of software components
You will be more preferable if you have the following.
- Bachelor's degree with scientific or engineer focus
- In-depth knowledge of ISO:13485, ISO:14971, CE marking, MDR, FDA 510(k)
- Experience in Software validation IEC:62304 and SaMD process certification
- Bilingual or with good knowledge of a second language
Please get apply to this advert if you feel like you would be a good fit for this position. Please also feel free to email me on firstname.lastname@example.org or call me on 07729712538.
SRG are a leading Medtech recruitment agency and if you work in QARA or engineering please reach out if you are looking for a new challenge or looking to add to your team.
your application has been submitted