Vacancy: QA/RA Officer
QA/RA specialist for ScreenPoint Medical
ScreenPoint is a medical device company that started as a spin-off from Radboud University Medical Centre. The company develops software for early detection of breast cancer using artificial Intelligence (AI). With its product Transpara for automated reading of mammograms ScreenPoint is internationally leading. The product is approved in the EU and has regulatory clearance by FDA for marketing in the US. Products of ScreenPoint are developed by a strong team of scientists and software engineers and the company is rapidly growing to deliver high quality services to hospitals worldwide.
ScreenPoint is looking for an enthusiastic and ambitious QA/RA specialist to join the Quality and Regulatory team. The company is ISO 13485 certified and is registering its products for international markets. As a QA/RA specialist you will be working in the Regulatory and Quality team, to ensure compliance with applicable quality and regulatory requirements and standards. You will contribute to the development and improvement of the quality management system and will promote quality procedures within the company.
Knowledge of ISO13485: 2016 and regulations in the field of medical devices; Experience with US FDA CFR820 (QMS) is a plus.
Experience in implementing quality management system or quality improvements, especially with software products.
Experience with product registrations of medical devices within Europe. Other countries is a plus.
Skills in managing and motivating people for achieving high quality.
Keen to progress your career as a QA/RA Officer in an innovative healthcare company
Ability to speak and write in English fluently
Competitive salary applies.
For more information please contact us via firstname.lastname@example.org.
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