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.

- Strong 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.

- Robust analytical, documentation, and communication skills.

- Exposure to US FDA or global registrations is an advantage.

📌 Medical Device Compliance Engineer (Pune)
🏢 Recognized
📍 Pune