Rosa Castaneda Email & Phone Number

México

- SME in Global Medical Devices Regulation- Manage, coordinate, and document internal regulatory processes.- Support in product registration, including new product registration, amendment, and renewals. - Responsible for Managing and notification of Significant Changes to different Notified Bodies.- Led the implementation and deployment of Mexican Standard.

Tijuana, Baja California, México

• Coordinator of the Environmental, Health, and Safety Management System based on ISO 14001 and45001, at Medtronic Tijuana Site, ensuring corporate & regulatory compliance with government entities.
• Lead of the ISO 14001:2015 Certification by an International Certification Agency and CleanIndustry Certification by Mexican Environmental Agency.
• Global EHS-Lead Auditor for Medtronic intercompany plants and suppliers.
• Lead the implementation, standardization & maintenance of the recycling program reaching torecycle 2,000 tons per year.
• Lead the design, installation, and operation of the hazardous materials warehouse.
• Lead the design, installation, and star up of the wastewater treatment system.

Mexico

Provided advice, audits and train as external auditor and coach in Management Systems and Regulatory Compliance for different companies such as Construction, Pharmaceutical, Electronics, Testing Laboratories, Calibrations Laboratories, Clinical and pathology laboratories, Certification bodies, Inspection bodies- Lead Certified Auditor and Implementer for.

Guadalajara, Jalisco, México

• Responsible of the Management Systems (headquarters and sites: Guadalajara, PuertoVallarta, Celaya andMonterrey), including Quality System, Regulatory Compliance, EHS, andLaboratory Testing Quality Assurance.
• Implement and lead the sustain the quality management system for ISO 9001:2008 certification.
• Lead the accreditation of 31 testing methods under the ISO 17025:2006.
• Responsible of the EHS Management System.Radiation Safety Responsible under the National Commission of Nuclear Safety.

Guadalajara, Jalisco, México

• Implemented and accredited the quality system according to ISO 17025:2006 for Testing Laboratory.
• Provided advice, coaching, training, and audit to organizations and companies in EHS Regulations and Standards.
• License and registration renewals in compliance with EHS local and global regulations.

Guadalajara, Jalisco, México

• Implemented and accredited the quality system according to ISO 17025:2006 for Testing Laboratory.
• Provided advice, couch, and audit to different organizations and companies in EHS Regulations and Standards.
• License and registration renewals in compliance with EHS local and global regulations.

Guadalajara, Jalisco, México

Lead the Implementation of the Statistical Process Control Program