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) Awareness of other regulation as determined by product availability (including ANVISA, MHRA/NHS, TGA, FDA) Desirable Requirements  Strong problem solving and project management skills; Excellent communication (verbal and written), research, organizational and interpersonal skills  Ability to work independently towards deadlines and strong attention to detail Expert PC operation skills, including knowledge of enterprise-wide software applications Knowledge of Microsoft Office applications required (Intermediate to Advanced preferred) QMS tools (document & records control systems, regulatory clearances, KPIs)  We are Dedalus, come join us Dedalus is committed to providing an engaging, rewarding work experience that reflects the passion our employees bring to our mission of helping clinicians and nurses deliver better care to their served communities.

 Our company fosters a culture where employees are encouraged to learn and innovate, and to enable and enhance clinical co-operation and processes while making a meaningful difference for millions of people around the world. Each person is the end point and the starting point of the Group’s activities and the ultimate beneficiary. For this reason, we are so proud of doing our very special jobs each day.  Our company is enriched by a diverse population of 7,600 people in more than 40 countries that work together to innovate and drive better healthcare options for millions of patients around the world.

We are the people of Dedalus.  Application closing date: 1st October 2025 Our Diversity & Inclusion Commitment sets out Dedalus’ approach to ensuring respect, inclusion and success for all our colleagues and the wider communities we operate in. It is imperative for us to share our commitment and dedication to ensure an inclusive and diverse workplace. We recognise that we have improvements to make, and, on this journey, we must remain authentic and realistic but also ambitious.  Our diversity & inclusion commitment – Dedalus Global Life Flows Through Our Software