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.
* Solid analytical, documentation, and communication skills.
* Exposure to US FDA or global registrations is an advantage.

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