לצערנו המשרה כבר לא בתוקף

RA and QA Manager

7 שנים ומעלה |
משרה מלאה
| 30/05/2022
תיאור משרה

Build Regulatory strategy
Lead FDA and MDD / MDR regulatory submissions of class III medical devices
Responsible for establishment, maintenance and management of the company's Quality Management System
Support the R&D team in design control processes related to DHF such as: Verification and Validation testing, risk management and engineering change control
Responsible for the development and maintenance of the DMR and DHR
Develop and review design documents
Lead company compliance audits

דרישות התפקיד

Relevant degree (biology/ engineering)
Experience leading RA and QA of medical devices
Proven knowledge with US and EU regulations and product lifecycle processes
Proficient in regulatory and technical writing
English - full proficiency
Advantages:
Experience with PMA regulation path
Experience with pre- clinical and clinical requirements
Experience from international / global companies

* משרה זו פונה לנשים וגברים כאחד.