Regulatory Affairs Specialist
1 miesiąc temu
- 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).
- Cooperating with QMS department on daily basis.
- Occasionally contacting Notified Bodies.
- Preparation of PMPFs.
- Coordination of performance evaluations.
- Other, as per IVDR & FDA requirements.
- Preferable: experience with FDA.
- 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 FDA.
- Solid knowledge of FDA 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.
- Join a team of passionate, forward-thinking regulatory professionals dedicated to overcoming challenges and pushing the boundaries of innovation. At our company, you’ll 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.
- 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
- Join a team of passionate, forward-thinking regulatory professionals dedicated to overcoming challenges and pushing the boundaries of innovation. At our company, you’ll 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.
Bacteromic is a flagship medtech system developed by Scope Fluidics Group, that addresses bacterial antibiotic resistance, one of the fastest-growing global medical threats.
Through the determination and expertise of our team of biotechnologists, engineers, and programmers, and an innovative approach to contemporary diagnostic challenges, we have created a device with significant market potential that has the opportunity to revolutionize antibiotic treatment.
Scope Fluidics is a biotechnology company operating in a Venture Studio model, which achieved the largest transaction in the history of the Polish life science market in 2022.
Wszystkie informacje o przetwarzaniu danych osobowych w tej rekrutacji znajdziesz w formularzu aplikacyjnym, po kliknięciu w przycisk "Aplikuj Teraz".-
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{"text":"Regulatory Affairs Specialist
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