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.
