ra&qa manager

a dedicated and detail-oriented QA & RA expert . In this role, you will ensure product quality and regulatory compliance by maintaining the QMS and adhering to FDA, CE, and ISO standards. You will collaborate with various departments to drive regulatory activities, such as preparing dossiers and managing communications with regulatory authorities in a dynamic, multi-project environment.

דרישות:

BSc or MSc degree in Life Sciences, Engineering, Chemistry, or other relevant fields – mandatory.

- 2-4 years of experience in QA and/or RA roles within the medical devices industry.

- Strong knowledge of ISO 13485, ISO 14971, MDR, and FDA 21 CFR 820 standards.

- Experience working in cleanroom environments is a significant advantage.

- Ability to thrive in a multi-tasking environment while meeting deadlines.

- High level of English, including technical writing skills.