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.