Medical Device Compliance Engineer

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.


• Strong analytical, documentation, and communication skills.


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