עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!

במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.

מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.

חברה בתחום ייצור ותעשייה

יקנעם עילית

חברה בתחום ייצור ותעשייה

יקנעם עילית
מלאה
18,000-26,000 ₪ (הערכה מבוססת AI)
הערכה מבוססת AI ולא שכר של המעסיק

Lead and manage clinical regulatory submissions, including IDE submissions, IRB/EC applications, amendments, and ongoing study maintenance.
Serve as the regulatory lead for US and EU clinical investigation activities, supporting first?in?human, feasibility, and pivotal studies.
Prepare, review, and maintain clinical regulatory documentation, including protocols, Investigators Brochures, clinical risk sections, and regulatory responses.
Support regulatory strategy development for clinical programs, ensuring alignment with development, clinical, and business objectives.
Act as a primary regulatory interface with FDA and European regulatory bodies related to clinical studies.
Collaborate closely with Clinical, R D, Quality, Biostatistics, Operations, and external clinical partners/CROs.
Participate in cross?functional discussions supporting new product development and clinical evidence

Requirements:
Minimum 4 years of experience in Regulatory Affairs within the medical device industry (not pharma).
Hands?on experience with clinical submissions (e.g., IDE, IRB/EC) is strongly preferred.
Experience with multidisciplinary medical devices (hardware, software, invasive systems).
Strong understanding of US and EU clinical regulatory frameworks.
Proven ability to independently author and lead complex regulatory submissions.
Assertive, proactive, and capable of working independently in a fast?paced environment.
Excellent command of English, written and spoken.
Motivation to grow and remain in the role for several years.

This position is open to all candidates.