Medical Quality Regulatory Manager

Solectron Corporation is seeking a Quality Regulatory Manager to develop, implement, and coordinate quality and regulatory compliance programs applicable to the medical device industry segment. The successful candidate will lead the efforts to ensure compliance with internal company policies and procedures as well as international quality system standards (e.g., ISO 13485) and regulations (e.g., 21 CFR 820). The incumbent will provide global leadership to Solectron facilities participating in the medical device industry and will assist in management of the relationship with the third party notified body. This position is located in Charlotte, North Carolina.
This position requires a Bachelor degree in Engineering or related field and a minimum of 8 years experience developing, implementing, and maintaining regulatory systems in the medical device industry. The successful candidate will have strong customer and supplier interface skills and experience with regulatory agency inspections, customer compliance audits, and international requirements. RAC certification through the Regulatory Affairs Professional Society is a plus, as is previous Class III medical device and electronics manufacturing experience.
REQUIREMENTS
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