Regulatory Compliance Officer
1 week ago
Job Responsibilities
- 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.
- Must be able/willing to travel globally.
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