Quality Assurance and Regulatory Affairs Analyst

**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 Analyst is responsible for implementing and maintaining local Quality and Regulatory strategies, including QMS processes development, scalability and simplification.
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.
- Ensures regulatory product registrations are obtained and maintained as required.
- Act as focal point for document collection of RA registration processes.
- Act as focal point of communication between the factory and the certification body and stakeholders involved.
- Support QMS activities: management reviews, internal/suppliers audit and CAPA´s
- Prepare registration dossiers and maintain Regulatory affairs documentation updated and organized to support compliance with applicable regulatory requirements.
- Management of electromedical product certificates, interacting with factories and INMETRO/ANATEL certification bodies.
- Assist in planning and executing Certification audits.
- Ensures that required Align entity and suppliers regulatory licenses/permits have been obtained and are maintained accordingly, being a point of contact with the areas involved;
- Assist in the maintenance of sanitary and technical licenses.
- Provide reports to Regulatory Authorities in accordance with current legislation (field actions, robberies).
- Approve Advertising & Promotional materials distributed to local market.
**In this role, you'll need **
- Minimum of 2 years in Quality Assurance and Regulatory Affairs role with Medical Devices;
- Knowledge of ANVISA regulatory requirements for medical devices, including product registration and good distribution practices from country scope.
- Knowledge of the Electromedical Certification process for Medical Devices.
- Knowledge of the Telecommunication Certification process for Medical Devices.
- 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
- Advanced Microsoft Office skills, including Word, PowerPoint and Visio
- Advanced English
- Basic spanish
**Sound like a good fit?**
Great Click the "Apply" link to let us know you are interested. Not the right fit? Don't worry, Align is quickly growing so we are creating more opportunities to expand our Align family. Please consider joining our Talent Network to receive notifications about future jobs or sharing this opportunity with others in your network.
**About Align**
Align Technology is a publicly traded medical device company that is **transforming smiles and changing lives**. Our global team of talented employees develop innovative technology, tools and treatment options to help dental professionals worldwide achieve the clinical results they expect. Our digital ecosystem combines the power of technology to create beautiful smiles through the integration of AI and machine learning, digital imaging and visualization, biomechanics and material science to develop the Invisalign system, the most advanced clear aligner system in the world; iTero Intraoral Scanners and OrthoCAD digital services. Did you know? Align is the world's largest manufacturer of custom 3D-printed materials.
**Global Diversity Statement**:
At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we will continue building a workforce of diverse cultural backgrounds and life experiences and fostering a culture of open-mindedness and compassion for all our employees. We live our company values by promoting healthy people and healthy communities. All with the intent of changing millions of lives, one unique smile at a time.
**Equal Opportunity Statement

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