Global Regulatory Affairs & Quality 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 is seeking an experienced professional for their Medical Division, focusing on regulatory affairs and quality compliance. Key tasks include developing strategies to align with regulatory guidelines, liaising with relevant agencies, and reviewing documentation. Candidates should have a Bachelor's degree in a scientific discipline and at least 7 years of experience in a quality and regulatory environment. Strong communication skills and knowledge of FDA regulations are essential.

Qualifications

• A minimum of 7 years experience in a Quality/Regulatory and manufacturing environment is required.
• Experience with device submissions (510K, PMA, IDE) is a plus.
• Must be proficient with technology and demonstrate professionalism.

Responsibilities

• Develop and implement strategies for the worldwide medical division.
• Liaise with FDA and regulatory agencies, ensuring compliance.
• Review technical reports for regulatory adherence.
• Prepare and review Standard Operating Procedures as necessary.

Skills

Communication Skills

FDA Regulations Knowledge

Project Management

Professionalism

Education

Bachelor's Degree in a Scientific Discipline

Tools

MS Office Software Package

Job description

A global technology company in Singapore is seeking an experienced professional for their Medical Division, focusing on regulatory affairs and quality compliance. Key tasks include developing strategies to align with regulatory guidelines, liaising with relevant agencies, and reviewing documentation. Candidates should have a Bachelor's degree in a scientific discipline and at least 7 years of experience in a quality and regulatory environment. Strong communication skills and knowledge of FDA regulations are essential.