Rge Pte Ltd
Quality, Regulatory & Compliance Manager - Mexico
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The objective of this role is to provide quality, regulatory affairs, and compliance leadership and expertise to the ORTHO Mexico commercial organization. This position is responsible for ensuring regulatory compliance requirements are met in accordance with Mexico’s national IVD regulations, and is accountable for maintaining a collaborative relationship with the national regulatory agency, COFEPRIS. As the appointed Sanitary Responsible Person for Ortho Mexico, this position functions as the primary regulatory correspondent and controls all device registrations for Ortho Mexico
- Operate as the quality and regulatory lead for Ortho Mexico and partner heavily with Ortho Global Quality Systems, Ortho International Regulatory Affairs, and Regional Ortho LATAM leadership to drive improvements in quality and compliance, including deployment of Ortho policies and deliver successful regulatory strategies to drive commercial growth. Partner with external regulatory consultants as required
- Incorporate Ortho global Quality Management System into Ortho Mexico and develop and implement any local quality procedures specific to Ortho Mexico. To Ensure operational compliance to FDA/ISO and Mexico regulations
- Escalate relevant quality and compliance issues within Ortho, facilitating the non-conformance and CAPA processes, ensuring compliance with customer complaint process, and all quality assurance components for Ortho Mexico
- Proactively monitor, analyze and improve all aspects of quality compliance, quality control and customer complaint process
- Perform in country Spanish quality review, copy review and approval of all promotional and regulatory materials (brochures, websites, labeling) in compliance with Ortho requirements and national regulatory requirements
- Provide regulatory expertise to global and local commercial teams to facilitate product launches and escalate issues to business partners that affect regulatory compliance and continued lifecycle management of the products. Determine IVD risk classification and select the appropriate registration route
- Prepare and submit registration dossiers to COFEPRIS for new product registrations, amendments, revalidations and cancellations as per regulation. Conduct registration renewals on a timely basis
- Perform timely assessment of Product Change Notifications from International RA and feedback the selected regulatory pathway in a timely manner
- Monitor national regulatory environment and externally influence legislative modernization. Feedback any risk or impact to Ortho International Regulatory Affairs.
Minimum Education or Equivalent Experience Required/Preferred
Bachelor Degree in Chemistry / Pharmacy with Professional License for Sanitary Responsible
Bachelor’s degree or equivalent in a scientific discipline, advanced degree an asset (MSc, PhD)
Strong knowledge of Mexican regulatory/compliance requirements along with relevant technical and procedural regulatory guidance documents applicable to IVDs.
Fluent in English and Spanish (advanced verbal and written comprehension)
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Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected]
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