Regulatory Compliance Officer

Job description

Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors.

Sanmina Corporation has facilities strategically located in key regions throughout the world.

Regulatory Compliance Officer Job Purpose

Sanmina, Carrollton, Texas is looking for a Regulatory Compliance Officer to coordinate and prepare documentation packages for regulatory submissions, internal audits and inspections from all areas of the company.

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) Sanmina is an Equal Opportunity Employer