Regulatory Compliance Officer

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

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.