Quality Assurance And Regulatory Affairs Analyst | [PUF748]

Quality Assurance And Regulatory Affairs Analyst | [PUF748]

**Join a team that is changing millions of lives.
**

Transforming smiles, changing lives

At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next.
We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation.
Our diverse and collaborative teams are constantly pushing the boundaries of what's possible.
Ready to join us?
**About this opportunity**

The Quality Assurance and Regulatory Affairs Sr. Analyst is responsible for implementing and maintaining local Quality and Regulatory strategies, including QMS process development, scalability,



and simplification.
Develop local Quality System plan according to business needs, enhancing Quality culture in the country's governance, and working together with peers on processes implementation and improvement.
Responsible for supporting regulatory strategies and accomplishing product registrations, ensuring local regulatory requirements are properly addressed/communicated

**In this role, you will**
- Ensures that local regulatory requirements and Global Align policies that impact the Quality System are appropriately addressed by relevant QMS procedures.
- Maintain the corporate RA duly updated about any new regulations, submissions dates and local approvals
- Assure the Company complies with Local Regulatory Affairs requirements and regulations and with Corporate Regulatory Affairs policies and procedures.
- Develop and maintain the main metrics for the RA function updated to ensure periodic reports will be ready available for monitoring and tracking purposes.
- Support QMS activities: management reviews, internal/suppliers audit and CAPA´s




- Ensures communication of key messages pertaining to Quality across the country organization.
- Ensures regulatory product registrations are obtained and maintained as required.
- Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements
- Ensures market clearance or approval and appropriate country licenses and certificates for new products and changes to existing products.
- Participate in multidisciplinary teams and communicate regulatory requirements effectively.
- Processing regulatory documentation requests from authorized distributors and local business entities and evaluating upcoming renewals.
- Ensures that required Align entity and critical suppliers' regulatory licenses/permits have been obtained and are maintained accordingly.




- Ensures that regulatory post-market obligations, including complaint reporting, nonconformity management, and CAPA are adequately documented and addressed in a timely manner.
- Keep pertinent stakeholders within the company apprised of any changes to the regulatory landscape affecting existing and new Align products or Quality System.
- Actively participation at local Industry Association meetings and events to advocate on behalf of Align and to monitor, sensing, and influence the regulatory environment.
- Support and Approve Advertising & Promotional materials distributed to the local market, as well as critical suppliers classified as QMS relevant.
**In this role, you'll need **




- Minimum of 2 years in Quality Assurance and Regulatory Affairs role with Medical Devices; Desirable experience with Medical Devices Class II (dental supplies and medical equipment)
- Knowledge of regulatory requirements for medical devices, including product registration and good distribution practices from Mexico.
- Ability to work cross-functionally with multiple projects, solving problems and communicating issues.
- Ability to execute project/program tasks with general supervision and little guidance.
- Bachelor's Degree in Pharmacy, Odontology, Engineering, Business Administration, or similar (graduated)
- Advanced Microsoft Office skills, including Word, PowerPoint, and Visio
- Advanced English and Spanish

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.com.mx/empleo/134603359/quality-assurance-and-regulatory-affairs-analyst-puf748-xico/?utm_source=html