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edag group

Medical Device Compliance Engineer

edag group
Pune, India
5-10 Years
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  • Posted 22 hours ago
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Job Description

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.

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Medical Device Regulatory Affairs
Employment Type:
Full time

About Company

edag group

Job ID: 150857455

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Last Updated: 07-07-2026 08:18:02 AM
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