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.
הרקלס גיוס השמה
- חיפה
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הרקלס גיוס השמה
- חיפה
-
מלאה
-
25,000-35,000 ₪
(הערכה מבוססת AI)
הערכה מבוססת AI ולא שכר של המעסיק -
A leading medical device company developing innovative products for global markets is seeking an experienced Senior QA /RA Manager to lead Quality Assurance and Regulatory Affairs.
Key Responsibilities:
Lead QA /RA activities in compliance with FDA, ISO 13485, MDR MDSAP.
Manage and improve the QMS and ensure regulatory compliance.
Prepare and submit regulatory documentation, registrations and filings.
Monitor global regulatory requirements and assess their impact.
Lead FDA, ISO and Notified Body audits and manage certifications.
Oversee CAPA, nonconformities, complaints, PMS and risk management.
Serve as Management Representative and PRRC under EU MDR.
Collaborate with R D, Engineering, Manufacturing and Operations throughout the product lifecycle.
Drive quality, continuous improvement and operational excellence.
Key Responsibilities:
Lead QA /RA activities in compliance with FDA, ISO 13485, MDR MDSAP.
Manage and improve the QMS and ensure regulatory compliance.
Prepare and submit regulatory documentation, registrations and filings.
Monitor global regulatory requirements and assess their impact.
Lead FDA, ISO and Notified Body audits and manage certifications.
Oversee CAPA, nonconformities, complaints, PMS and risk management.
Serve as Management Representative and PRRC under EU MDR.
Collaborate with R D, Engineering, Manufacturing and Operations throughout the product lifecycle.
Drive quality, continuous improvement and operational excellence.
Requirements:
10+ years of management experience in QA /RA within the medical device industry.
Strong knowledge of FDA regulations, ISO 13485, MDR, and MDSAP requirements.
Proven experience leading regulatory compliance programs, audits, and certification activities.
Experience working with international regulatory authorities and Notified Bodies.
Bachelor's degree or higher in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field.
Lead Auditor certification (e.g., IRCA) and/or RAC certification - an advantage.
Excellent leadership, communication, analytical, and problem-solving skills.
Fluent English - written and spoken.
10+ years of management experience in QA /RA within the medical device industry.
Strong knowledge of FDA regulations, ISO 13485, MDR, and MDSAP requirements.
Proven experience leading regulatory compliance programs, audits, and certification activities.
Experience working with international regulatory authorities and Notified Bodies.
Bachelor's degree or higher in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field.
Lead Auditor certification (e.g., IRCA) and/or RAC certification - an advantage.
Excellent leadership, communication, analytical, and problem-solving skills.
Fluent English - written and spoken.
This position is open to all candidates.
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.
מעלות-תרשיחא
288 שעות
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