Regulatory Affairs (6 month contract)

About the role

The role is responsible for ensuring market access and market continuity by executing product registrations and maintaining regulatory compliance in Singapore and Export Markets.

Responsibilities

• Ensure regulatory compliance in Singapore and the Export Markets.
• Compile registration dossiers for new product registrations or change notifications according to the regulatory plan and local regulatory requirements.
• Submit product registrations or change notifications to the relevant regulatory authorities and obtain approvals in a timely manner.
• Submit license renewals on time.
• Assess the impact of changes initiated by the Product Owner and work closely with the supply chain, manufacturing, and commercial teams to ensure no disruption to supply.
• Provide internal stakeholders with regular updates throughout the registration process.
• Monitor changes in the regulatory environment and formulate appropriate company responses to such changes.
• Report Field Safety Corrective Actions and Adverse Events to the relevant authority.
• Maintain regulatory databases and systems.

Requirements

• Education
• Bachelor's degree in any Engineering or Science-related discipline.
• 1-2 years of Regulatory Affairs (RA) working experience.
• Competencies
• Working knowledge of the regulatory controls governing medical devices in Singapore and Developing Markets.
• Good verbal and written communication skills.
• Keen to learn.
• Meticulous and detail-oriented.
• Effective interpersonal skills with the ability to build relationships with internal and external stakeholders.
• Interested candidates may apply through the application system. We regret to inform only Shortlisted candidates will be notified.
• PERSOL Singapore Pte Ltd - RCB No. 200007268E - EA License No. 01C4394 - EA Registration No. R1877971 (Derrick Tiew Yong Han)

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