
Medical Device Regulatory Specialist
10 hours ago
We are Magle Group, a value-driven organization that has an interesting journey ahead. We are looking for a talented Regulatory Affairs Specialist to support our medical devices business and ensure compliance with all regulatory standards and guidelines applicable in our active markets.
This role will be responsible for preparing and submitting regulatory documentation required for approval and registration in various international markets, as well as maintaining regulatory files and updating regulatory authorizations. The ideal candidate will have a strong understanding of international regulatory guidelines and standards, as well as excellent communication skills.
- Job Description:
- Preparation and submission of regulatory documentation for new and existing products.
- Maintenance of regulatory files and update of regulatory authorizations.
- Response to questions from regulatory authorities.
- Assessment of device-related incidents and complaints for medical device reporting requirements.
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.
- Proven track record in preparing successful regulatory submissions.
- Excellent communication skills.
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