Regulatory Affairs Lead, Medical Devices (FDA Focus)

ABIORES PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A medical device company based in Singapore is seeking a Regulatory Affairs Specialist to support product registration and compliance with FDA regulations. The role requires a Bachelor’s degree in a relevant field and at least 2 years of hands-on experience with FDA submissions. Key responsibilities include coordinating with CROs and regulatory authorities, project management, and fostering relationships with industry leaders. The ideal candidate is detail-oriented and willing to travel to the United States for stakeholder engagement.

Qualifications

• Minimum 2 years of experience with the FDA on medical device registration.
• Skills in planning, execution, and timely communication.
• Proactive work ethic with a strong level of accountability.

Responsibilities

• Support product registration activities and coordinate with CROs.
• Act as the expert on medical device regulatory requirements.
• Interface with global regulatory authorities and track submission progress.

Skills

Project management

Technical writing

Interpersonal skills

Detail-oriented

Education

Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering

Job description

A medical device company based in Singapore is seeking a Regulatory Affairs Specialist to support product registration and compliance with FDA regulations. The role requires a Bachelor’s degree in a relevant field and at least 2 years of hands-on experience with FDA submissions. Key responsibilities include coordinating with CROs and regulatory authorities, project management, and fostering relationships with industry leaders. The ideal candidate is detail-oriented and willing to travel to the United States for stakeholder engagement.