Global Regulatory Affairs Lead - Medical Devices

SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A global technology company in Singapore seeks a professional to develop and implement strategies for its medical division, ensuring compliance with regulatory standards including FDA requirements. The ideal candidate holds a Bachelor's degree in a scientific discipline and has at least 7 years of experience in a Quality/Regulatory environment. Strong communication skills and the ability to travel globally are essential for this role.

Qualifications

• Minimum of 7 years experience in a Quality/Regulatory and manufacturing environment.
• Experience with Device submissions is a plus (510K, PMA, IDE).
• Must demonstrate professionalism in all working environments.

Responsibilities

• Develop and implement strategies for the medical division.
• Serve as liaison with the FDA and regulatory agencies.
• Review technical reports for adherence to guidelines.
• Review technical reports for adherence to guidelines.
• Assist in tracking project and operational activities.

Skills

Expert knowledge of FDA regulations

Strong written and verbal communication skills

Proficient use of technology including MS Office

Education

Bachelor's Degree in a scientific discipline

Job description

A global technology company in Singapore seeks a professional to develop and implement strategies for its medical division, ensuring compliance with regulatory standards including FDA requirements. The ideal candidate holds a Bachelor's degree in a scientific discipline and has at least 7 years of experience in a Quality/Regulatory environment. Strong communication skills and the ability to travel globally are essential for this role.