Medical Devices Compliance Specialist

2 weeks ago


Madurai, Tamil Nadu, India beBeeRegulation Full time ₹ 75,00,000 - ₹ 1,50,00,000

We are seeking an experienced professional to join our team as a Medical Devices Complaints Specialist. The ideal candidate will have a strong background in medical device regulations and experience in complaints management.

Job Description

The successful candidate will be responsible for handling medical device customer allegations in a complaints management system. They will work closely with cross-functional teams to execute projects and initiatives, drive efficiency and continuous improvement in complaints remediation using work instructions and compliance to processes.

Key responsibilities include:

  • Managing daily work allocation and providing daily status updates to leads
  • Collaborating with cross-functional teams to execute projects and initiatives
  • Driving efficiency and continuous improvement in complaints remediation using work instructions and compliance to processes
Requirements

To be considered for this role, applicants should have:

  • A minimum of 2-7 years of experience in medical devices complaints handling or PMS activities
  • A working knowledge of global medical device regulations, such as CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971
  • Excellent written and verbal communication skills
  • Ability to adapt to cross-cultural differences and work in a timeline-driven environment


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