Regulatory Compliance Officer (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

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.