נכון לתאריך
19/12/2025
נתניה
Manpower Israel
Regulatory Affairs Manager – Post Market
A leading medical device company is seeking a Regulatory Affairs Manager to lead the Post Market RA team and ensure compliance across global markets.
Key Responsibilities:
✔ Manage post-market regulatory activities and team operations
✔ Support product design and post-market compliance from a regulatory perspective
✔ Handle vigilance, MDR, and authorities’ inquiries regarding complaints
✔ Oversee regulatory aspects of investigations
✔ Manage product field actions and QMS-related regulatory assessments
✔ Maintain company PSUR reports
Requirements:
✅ BSc in a scientific field (Biomedical or Quality Engineering – advantage) or recognized regulatory course graduate
✅ 2–4 years of post-market experience in medical devices/pharma
✅ Knowledge of EU, Canada, and US regulatory systems (additional regions – advantage)
✅ Minimum 2 years of management experience
✅ Strong communication skills (verbal & written)
✅ High technical aptitude and experience with regulatory authorities
✅ Understanding of risk management principles
✅ English – very high leve
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