
Medical Devices Compliance Specialist
2 weeks ago
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 DescriptionThe 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
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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