Device Registration and Compliance Professional
7 days ago
Ensuring Regulatory Compliance
Magle Group is committed to ensuring regulatory compliance and seeks an experienced Device Registration and Compliance Professional. The successful candidate will have a strong understanding of international regulatory guidelines and standards.
Key Responsibilities:
- Prepare and submit regulatory documentation required for the approval and registration of new and existing products in various international markets.
- Stay up-to-date on regulatory procedures and changes in the regulatory climate to ensure compliance and advise the company on necessary adjustments.
- Manage legalization of registration documentation and maintain regulatory files.
- Inform and educate the organization on submission requirements and ensure necessary documents are provided.
Requirements:
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs, specifically with medical devices.
- Strong understanding of international regulatory guidelines and standards such as FDA, CE Marking, ISO 13485, MDR, etc.
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