Regulatory Compliance Officer (Medical Devices)

SANMINA-SCI SYSTEMS SINGAPORE PTE. LTD.; Singapore; On-site; SGD 75,000 - 95,000; Full time

Job summary

A leading medical devices company in Singapore is looking for a senior professional to enhance their Medical Division. The candidate will develop regulatory strategies and ensure compliance with FDA standards. Responsibilities include reviewing reports, preparing Standard Operating Procedures, and liaising with regulatory agencies. Ideal candidates have a Bachelor's degree in a scientific field and at least 7 years of experience in quality/regulatory roles. Strong communication skills and global travel readiness are essential.

Qualifications

• At least 7 years experience in a Quality/Regulatory and manufacturing environment.
• Experience with Device submissions (510K, PMA, IDE) is a plus.
• Must demonstrate professionalism in all working environments.
• Must be able/willing to travel globally.

Responsibilities

• Develop and implement strategies for the Medical Division.
• Work with facilities on quality and regulatory initiatives.
• Serve as liaison with the FDA and regulatory agencies.
• Review technical reports for adherence to guidelines.
• Contribute to company practices for quality and regulatory affairs.

Skills

Strong written and verbal communication

Expert knowledge of FDA regulations

Proficient in MS Office

Education

Bachelor's Degree in a scientific discipline

Job description

Job Responsibilities

• Develop and implement strategies to facilitate the progress of Sanmina’s worldwide medical division.
• Work with assigned Medical Division facilities on conformance to company quality and regulatory initiatives.
• Serve as liaison with the FDA and other regulatory agencies as assigned; Interface with plant management teams, customers and notified bodies as assigned;
• Review technical reports and summary documents for adherence to regulatory guidelines, strategies, and commitments.
• Recommend regulatory policies to assure adherence to FDA requirements.
• Contribute to the modification, development and implementation of company practices and policies for quality and regulatory affairs.
• Assist in the scheduling and tracking of project and operational activities for the Medical Division.
• Keep abreast of all pertinent laws, regulations and guidance and provide insight on current regulations and guidance documents relevant to product development projects.
• Provide input on regional regulatory strategies and implementation activities.
• Prepare Standard Operating Procedures and provide review of SOPs as necessary.

Job Requirements

• Bachelor's Degree in a scientific discipline.
• At least 7 years experience in a Quality/Regulatory and manufacturing environment.
• Experience with Device submissions is a plus. (510K, PMA, IDE).
• Expert knowledge of FDA regulations.
• Strong written and verbal communication skills necessary.
• Proficient use of technology including MS Office Software Package and Internet resources is expected.
• Must demonstrate professionalism in all working environments.
• Must be able/willing to travel globally.