QARA Associate
QARA AssociateTewkesbury 30-40K DOEFull-time permanentAre you looking to build your career in Quality and Regulatory Affairs within a company committed to continuous improvement and global compliance? Do you want to be part of a collaborative team working with ISO13485 and MDSAP standards?If the answer is yes to all of the above, then Thomas Professional may have the role for you!Thomas Professional is delighted to be exclusively supporting a growing medical device business to manage the recruitment for a QARA Associate to join their team on a full-time, permanent basis.Benefits: Private healthcare 25 days annual leave + bank holidays Continued professional development Opportunity to join a growing business where your career can truly flourish As a QARA Associate you will: Maintain and evolve the companies electronic QMS in line with ISO13485 and MDSAP Manage routine validation of the QMS Monitor quality objectives and KPIs Conduct internal audits and support external audits Prepare and implement quality and regulatory policies and procedures Support regulatory submissions and post-marketing obligations Assist with training and awareness across the business Monitor and interpret changes in relevant regulations and standards To be successful as a QARA Associate, you will: Have 1-3 years experience in QA/RA, ideally within medical devices or healthcare Hold a degree in life sciences, medical engineering or similar Have an understanding of ISO13485, FDA Regulations and MDR/MDD B
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