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MEDIVENA sp. z o.o.

Quality & Regulatory Affairs Manager (K/M)

MEDIVENA sp. z o.o. Show all offers
Lublin
Warszawa
Expires Oct 4, 2026
14 days ago

In short

Role: Quality & Regulatory Affairs Manager. Responsibilities: Manage QMS (ISO 13485, MDR, FDA), lead medical device registration, prepare technical documentation, support R&D, conduct audits. Requirements: 3-5 years QA/RA experience in medical devices, MDR/FDA registration, ISO 13485/14971, English. Benefits: training subsidies, remote work option.

Keywords

QA/RA MDR FDA ISO 13485 ISO 14971 QMS 510(k) audits

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Published 2026-09-04
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