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)
