Quality and Regulatory Specialist (Medical device technical documentation)

Quality and Regulatory Specialist (Medical device technical documentation) Miejsce pracy: Warszawa Your responsibilities Preparation of technical documentation for IVDs & FDA various risk classes. Post-marketing surveillance activities. Participating in compliance / QMS audits. Drafting / updating regulatory processes (procedures & records). Quality Management responsibilities: preparing & updating procedures, records. Occasionally contacting Notified Bodies. Preparation of PMPFs. Coordination of performance evaluations. Other, as per IVDR & FDA requirements. Our requirements Higher education in biotechnology, life and medical sciences, maths/physics, biomedical engineering, philosophy or a related field. Documented minimum of 2 years of experience with regulatory compliance based on IVDR and/or FDA. Solid knowledge of IVD/MD requirements and related MDCG & IMRDF requirements. Attention to detail and ability to work independently, set task priorities, and meet deadlines. Proficiency in English (B2 or above) – note that all procedures and technical documents will be written in English, some team mates also speak English only. Experience with ISO13485. Optional Experience with FDA. What we offer Join a team of passionate, forward-thinking regulatory professionals dedicated to overcoming challenges and pushing the boundaries of innovation. Work in an energetic environment where problem-solving is key, and every team member is driven by a shared vision of advancing medical technology. Embrace the opportunity to contribute to groundbreaking projects and make a tangible impact on the future of healthcare. Benefits sharing the costs of sports activities private medical care sharing the costs of professional training & courses flexible working time fruits integration events no dress code coffee / tea Bacteromic Sp. z o.o. Bacteromic is an innovative medical diagnostics company with the goal of helping patients fight antibiotic-resistant bacteria through our innovative diagnostic solutions. Our technologies and products are changing the way healthcare professionals diagnose and treat bacterial infections, including sepsis. Wszystkie informacje o przetwarzaniu danych osobowych w tej rekrutacji znajdziesz w formularzu aplikacyjnym, po kliknięciu w przycisk "Aplikuj Teraz".

Location: Warszawa, PL

Posted Date: 4/19/2025