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Medical Devices Compliance Specialist
3 weeks ago
HCL Technologies Limited is a leading global technology company that empowers businesses to drive digital transformation and innovation. Our mission is to harness the power of technology to help our clients succeed in an ever-changing world.
Job OverviewWe are seeking a highly skilled Medical Devices Compliance Specialist to join our team. This individual will be responsible for ensuring compliance with relevant medical device regulations, requirements, and standards.
Key Responsibilities:- Develop and maintain knowledge of applicable medical device regulations, including CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Investigate and resolve complaints related to medical devices.
To be successful in this role, you will need:
- 2-7 years of experience in medical device complaints handling or PMS activities.
- A working knowledge of global medical device regulations, requirements, and standards.
- An excellent communicator with strong written and verbal skills.
- The ability to adapt to cross-cultural differences.
- Familiarity with timeline-driven environments.
