Regulatory Affairs Specialist

1 miesiąc temu


Warszawa mazowieckie, mazowieckie, Polska Bacteromic Sp. z o.o. Pełny etat
Regulatory Affairs Specialist (Medical device technical documentation)Miejsce pracy: WarszawaYour 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).
  • 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.
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 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.
What we offer
  • 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.
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
  • 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 Sp. z o.o.

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.

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