Regulatory Compliance Officer

Regulatory Compliance Officer Sanmina-SCI, a Fortune 500 Company headquartered in San Jose, California, is a leading Electronics Manufacturing Services (EMS) provider focused on delivering complete end-to-end manufacturing solutions to technology companies around the world. Our service offerings include innovative product design and engineering, test solutions, manufacturing, logistics and post-manufacturing repair/warranty services. Recognized as a technology leader with major global operations in over 20 countries and on five continents, we deliver customized and flexible solutions from design and engineering to individual components and complete systems. With an impressive global footprint and world-class manufacturing services, Sanmina-SCI continues to grow as leader in the EMS industry. Sanmina-SCI is an Equal Opportunity Employer. Sanmina-SCI offers comprehensive benefits because we care about the quality and balance of our employees' lives. We invite you to learn more about our opportunities at Sanmina-SCI.NATURE OF WORK: Develop and implement strategies to facilitate the progress of Sanmina-SCI'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.QUALIFICATIONS: • Bachelor's degree in a scientific discipline. • Expert knowledge of FDA regulations. • At least 7 years experience in a Quality/Regulatory and manufacturing environment. • Experience with Device submissions is a plus. (510K, PMA, IDE) • 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, approximately 7-10 times per year.ADDITIONAL INFORMATION: Offering the world’s largest medical device manufacturing infrastructure in the EMS industry, Sanmina-SCI’s Medical Systems Division has eight (8) exclusively devoted medical facilities in seven (7) countries. Please refer to job description.