RA Professional for Medical Devices

3 days ago


Singapore Recruit Express Pte Ltd. Full time
Regulatory Affairs Role
We are seeking a skilled RA professional to join our team as a Medical Device Regulatory Specialist. In this role, you will be responsible for ensuring that our medical devices comply with all relevant regulatory requirements. This includes preparing and submitting product registration tasks, such as new product registration, registration amendments, and renewal registrations.

Main Responsibilities:
• Prepare and submit product tests/samples to regulatory agencies for review and approval.
• Collaborate with lab technicians to ensure product tests/samples meet safety and performance requirements of regulatory agencies.
• Develop and implement strategies to improve regulatory compliance and reduce risk.
• Ensure that all marketing advertisements comply with regulatory requirements and submit to FDA for approval.
• Maintain accurate records of all regulatory activities, including product recalls and non-compliance issues.

Requirements:
• Degree in Biomedical/Material Science or relevant discipline.
• Minimum 3 years of experience in RA work, particularly in medical devices.
• Proven track record of success in regulatory compliance and management.
• Strong analytical and problem-solving skills, with ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.

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