Senior Regulatory Affairs Specialist
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Job Description
Senior Regulatory Affairs Specialist | Medical Devices | Singapore
Salary - $6,000 to $8,000+ SGD per month
Additional performance bonuses and benefits will apply.
We are partnering with an established medical device company in Singapore to hire an experienced Senior Regulatory Affairs Specialist to support global product registrations, regulatory strategy, and lifecycle compliance activities.
This is an excellent opportunity for a handsβon regulatory professional with strong experience in US FDA submissions , medical device registrations, and international regulatory compliance.
Key Responsibilities
- Lead regulatory strategy for new product launches and product changes
- Prepare and manage submissions including US FDA 510(k) , EU Technical Files, Design Dossiers, and other global registrations
- Coordinate renewals, variations, approvals, and marke...