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Medical Device Regulatory Compliance Specialist
vor 1 Woche
Job Summary:
We are seeking a highly skilled Medical Device Regulatory Compliance Specialist to join our team at Masimo. The successful candidate will be responsible for ensuring compliance with global medical device regulations, requirements, and standards.
About the Role:
- Prepare and coordinate country submissions for Medical Devices in EMEA.
- Process and maintain regulatory certificates, renewals, changes, and other documentation.
- Review RA documentation according to economic operators' obligations under MDR in the EMEA region.
- Assist in registrations to the MDD/ MDR in the EU and to national requirements and international regulations.
- Update technical documentation taking into account regulatory requirements.
About You:
- You have a solid understanding of global medical device regulations, requirements, and standards.
- You possess excellent communication skills and can work effectively in a team environment.
- You are able to prioritize tasks, manage multiple projects, and meet deadlines.
