Pre Market Quality and Regulatory Specialist (m/f/d)

Do you want a job with a purpose? And do you want to make healthcare safer, better and more reliable?Join our Team!Join us as our Pre-market QARA Specialist at Dedalus, one of the World’s leading healthcare technology companies, in Bosnia and Herzegovina to do the best work of your career and make a profound impact in providing better care for a healthier planet.  What you’ll achieve As Pre-market QARA Specialist, you will ensure ongoing Quality and Regulatory compliance of products and services.   You will have the following responsibilities:  You will drive and manage the implementation of the Dedalus Healthcare Quality Management System to the site Sarajevo and related teams on other sites. You will provide guidance and define regulatory plans and strategies, work with the project core team and be accountable for the implementation of the pre-market regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances. You will drive and monitor timely resolution of NC and CAPA records, identify areas for improvement, take part in the preparation and progress of internal and external audits and support quality management review, quality training and the document and records management process to maintain and improve compliance, making a profound impact across the healthcare sector.   Take the next step towards your dream career At Dedalus Life flows through our software. Every day we do something special by helping caregivers and health professionals deliver better care to their served communities. Take the next step in your career and help shape the future of healthcare. Here’s what you’ll need to succeed:   Essential Requirements   Minimum 3-5 years of experience in a regulated industry – preferably medical device, pharmaceutical or related – holding a position in quality management, quality assurance and regulatory affairs, or project management position. English (upper intermediate or better) Ability to analyse, understand, and interpret regulations and standards for a more general business audience Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, and new Medical Device Regulation MDR and IVDR. Knowledge of and experience in: Design control regulations and requirements Medical device classification rules and regulations Medical device regulatory submission regulations and requirements Risk management regulations and requirements Software development methodologies and practices CAPA/NC regulations and requirements Usability, safety, and product related standards Awareness of Medical Device product safety and Security Standards including ISO 27001, GDPR (Preferable) A...