Medical Device Regulatory Affairs Expert
4 days ago
Supporting Business Growth
Magle Group is expanding its operations and seeks an experienced Medical Device Regulatory Affairs Expert to support our business growth. The ideal candidate will have a strong background in regulatory affairs and experience working with medical devices.
Key Responsibilities:
- Prepare regulatory submissions, including IDEs, 510(k) submissions, and Canadian medical device licenses.
- Update regulatory authorizations, such as CE dossiers for the EU and NRTL certifications.
- Manage change control activities and respond to questions from regulatory authorities.
- Collaborate with cross-functional teams to ensure compliance with global regulatory 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.
- Excellent communication skills and ability to interact effectively at all levels of the organization.
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