Senior Regulatory Affairs Specialist (Medical Devices) | Up to $6,000 | Mon–Fri Office Hours

• Provide regulatory strategy and guidance to product development teams to support strategic planning, pre-marketing activities, and regulatory submissions
• Prepare, submit, and maintain regulatory filings for medical devices, including US FDA 510(k) submissions, EU Technical Files / Design Dossiers, and other global medical device licensing submissions where applicable
• Liaise with regulatory authorities on submissions, registrations, variations, and renewals to ensure continued market access
• Monitor and interpret new and evolving regulatory requirements, standards, and guidance, and perform regulatory impact and gap analyses
• Maintain and manage the product registration database, including tracking of submissions, approvals, renewals, and regulatory commitments
• Support regulatory compliance activities throughout the full product lifecycle, from development to post-market maintenance
• Maintain current knowledge of US FDA regulations, EU MDR, and other applicable international medical device regulatory requirements
• Manage Medical Device Reporting (MDR) and Vigilance reporting in accordance with applicable regulations
• Support Field Safety Corrective Actions (FSCA), including product recalls where required
• Perform other regulatory or project-related duties as assigned by management

• Attractive salary package of up to $6,000
• Stable Monday to Friday office hours
• Annual leave starting from 14 days, up to 18 days
• Opportunity to join a company in the medical devices / endoscopy industry
• Exposure to US FDA, EU MDR, and global regulatory submissions
• Suitable for candidates with strong experience in medical device compliance, regulatory documentation, and submission work

Applicants who possess relevant experience for the above responsibilities are most welcome to apply. If you do not possess the above experience, your application will still be considered on individual merits and you may be contacted for other opportunities.

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