Medical Device Compliance Specialist

1 week ago


Kozhikode, Kerala, India beBeeElectronic Full time ₹ 80,00,000 - ₹ 1,60,00,000

About this role:

We are seeking an experienced professional to deploy our Electronic Quality Management System (eQMS) with medical device and healthcare companies.

Responsibilities will include conducting training sessions, workshops, and onboarding programs for healthcare professionals and client teams.

The ideal candidate will have a strong understanding of compliance standards, such as ISO 13485 and FDA 21 CFR Part 11.

Key Responsibilities

  • Collaborate with clients to implement eQMS solutions.
  • Provide training and support to healthcare professionals.
  • Liaise with hospitals, laboratories, and device manufacturers.
  • Gather customer feedback and contribute to product improvements.

Requirements

  • Bachelor's or Master's degree in Biomedical Engineering, Clinical Engineering, Biotechnology, or equivalent.
  • Prior experience in medical devices, hospital equipment, or clinical applications.
  • Knowledge of compliance frameworks: ISO 13485, FDA 21 CFR Part 11, GxP, MDR.

What We Offer

  • A collaborative work environment.
  • Opportunities for growth and development.
  • A competitive compensation package.

Language Requirements

  • Fluency in English (written & spoken) is mandatory.

Soft Skills

  • Analytical and detail-oriented with strong documentation skills.
  • Empathy and patience while supporting clinical staff and clients.
  • Collaborative mindset to work with diverse stakeholders.


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