This will help you grow:
- Ensure compliance with EU MDR (2017/745) and IVDR (2017/746).
- Support regulatory strategies and submissions for EU and global markets.
- Perform product classification and regulatory gap assessments.
- Prepare and review technical documentation (Annex II & III, GSPR, traceability matrices).
- Develop Design Dossiers and manage document lifecycles.
- Support Clinical Evaluation Reports (CER), PMS, PMCF, and vigilance reporting.
- Ensure ISO 13485 compliance and support audits, CAPA, and change control.
- Support EUDAMED registrations and UDI requirements.
- Contribute to MDR/IVDR transition projects, audit readiness, and product lifecycle activities.

This is how you will help us move forward:
- 5–10 years’ experience in medical device regulatory affairs.
- Solid knowledge of EU MDR/IVDR requirements.
- Hands-on experience in technical documentation and clinical evaluation.
- Understanding of ISO 13485 and exposure to ISO 14971 preferred.
- Bachelor’s degree in Biomedical, Life Sciences, Pharmacy, or related field.
- Strong analytical, documentation, and communication skills.
- Exposure to US FDA or global registrations is an advantage.

📌 Medical Device Compliance Engineer (Pune)
🏢 EDAG Group
📍 Pune