Regulatory Specialist

Regulatory Specialist

Bacteromic Sp. z o.o.

Warszawa
regulatory compliance
IVDR
FDA
ISO13485
technical documentation
post-market surveillance
medical devices

Podsumowanie

Regulatory Specialist responsible for ensuring product compliance with regulations like ISO 13485 and IVDR. Requires 2+ years experience in regulatory compliance and proficiency in English.

Słowa kluczowe

regulatory complianceIVDRFDAISO13485technical documentationpost-market surveillancemedical devices

Benefity

  • opieka medyczna
  • możliwości pracy zdalnej
  • elastyczne godziny pracy
  • wydarzenia integracyjne
  • brak dress code'u

Opis stanowiska

Wymagania

Higher education in biotechnology, life and medical sciences, maths/physics, biomedical engineering, law 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., ISO13485 auditor training certificate.

Benefity

private medical care, remote work opportunities, flexible working time, integration events, no dress code

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Wyświetlenia: 2
Opublikowanaokoło 12 godzin temu
Wygasaza 30 dni
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