Support regulatory activities, including preparation and submission of product registrations for medical devices and IVDs to HSA and other regulatory authorities (e.g. EU IVDR, FDA).
Assist in ensuring compliance with applicable regulatory requirements and standards across all markets.
Support post-market regulatory activities, including product renewals, vigilance reporting, and change notifications.
Assist in maintaining and improving the Quality Management System (QMS) in accordance with ISO 13485, GDPMDS, and other applicable standards.
Ensure quality processes and documentation are aligned with regulatory requirements.
Prepare, review, and maintain quality and regulatory documentation, including SOPs, work instructions, and records.
Support internal and external audits (e.g. regulatory inspections, certification audits), including audit preparation and follow-up on corrective and preventive actio...
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