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המימד השלישי גיוס והשמה

Regulatory Affairs (RA) Director


 A global medical devices company in Caesarea is looking for a Regulatory Affairs (RA) Director.
* Develop, review, and provide regulatory input for design documents.
* Act as the liaison to RA teams for three Business Units, located in the company's headquarters in California.
* Provide strategic regulatory input to early-stage projects in the field of structural heart disease.
* Support FDA and MDD/MDR regulatory submissions of class II and class III medical devices, including submissions for first-in-human studies.
* Support rest-of-world regulatory submissions.

דרישות התפקיד

* B.Sc. or above in Engineering or Life Sciences.
* 10+ years of experience in RA positions in the medical device industry.
* English – full proficiency (mother tongue level).
* Proven knowledge of applicable regulations and product lifecycle processes for permanent.
implantable medical devices
* Proficient in regulatory and technical writing.
* Experience in international/global companies – an advantage.
* Experience in pre-clinical/clinical studies – an advantage.
* Experience in cardiology, familiar with structural heart diseases and therapies – an advantage.

כישורים נדרשים

* Strong execution, written and verbal communication, and interpersonal skills.
* Independent, meticulous, and detailed-oriented.
* High commitment, including willingness to travel abroad.