Regulatory Affairs Executive / Senior

Essential Duties and Responsibilities :

Regulatory Affairs Responsibilities :

• Assist in authoring, editing and reviewing of technical documents e.g. medical device verification & validation documents, standard operating procedures, risk management plans and reports for medical devices.
• Assist in the preparation, review and compilation of technical dossiers for the purpose of new device registrations and submission of change notifications to regulatory bodies.
• Provide key regulatory inputs to business development team to assist in achieving the company’s overall business objectives.
• Liaise closely and communicate effectively with key stakeholders on regulatory matters to aid in product commercialization.

Quality Assurance Responsibilities :

Work Experience Requirements :

Education Level Requirements :

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