Regulatory Compliance Officer

Nature of Duties

• 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.

Education and Experience

• Bachelor’s degree in a scientific discipline
• A minimum of 5 years experience in a Quality/Regulatory and manufacturing environment.
• Expert knowledge of FDA regulations
• Strong written and verbal communication skills necessary
• Proficient use of technology including MS Office and Internet resources
• Must demonstrate professionalism in all working environments.
• Must be able/willing to travel globally.
• Experience with Device submission is a plus. (510K, PMA, IDE)