Regulatory Affairs Manager

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