QA/RA Manager | Medical Device Start Up | £55,000pa | Cambridge
Plenty of engineer’s study for years, only to step into legacy tech, with lots of red tape & politics, which most probably do not envisage during their early & ambitious years. Why not take the opportunity to step into a business which envisages technology which addresses one of the biggest health concerns across the globe, with the financial & intellectual backing to make it a reality?
We are working with a Cambridge start-up, who have been created to change the status quo of respiratory treatments across the UK. We are currently looking for a Quality & Regulatory Assurance (QA/RA) Manager to lead on the regulatory and quality management aspects of a new generation of regulated hardware and software medical device products. You will provide regulatory input to technology, product development and strategy. As the QA/RA manager you will liaise with global regulatory authorities regarding the company’s QMS and product certification while helping to maintain the company’s QMS. You will monitor and report on Quality Objectives and Key Performance Indicators
There are only three essential skills needed:
- Relevant degree, higher diploma or equivalent in science or engineering
- At least two years hands-on industry experience in the quality/regulatory medical device field
- Operating in a Quality Assurance function under ISO 13485 and one or more of the Medical Device Directives, alternatively ISO 9001, ISO/TS 16949 or other similar quality management system standard
So, if you like the ad, or you’d at least like to know some more, what’s next? You have 3 options….
- Click the little apply button (don’t worry, we’ll discuss before your CV or application goes anywhere)
- Email me directly on firstname.lastname@example.org
- You can find me on LinkedIn (Louis Plevin), trust me there’s not many people with the surname Plevin