Align

More about the role

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 Regulatory Affairs Specialist is responsible for implementing and maintaining local regulatory strategies. Responsible for supporting local regulatory strategies and accomplishing filings for product submissions and registrations, ensuring local regulatory requirements are communicated. This position reports to KR RAGAQA Sr manager.

In this role, you will… 

• Provides expertise to support business efforts locally based on RA requirements, and any other applicable worldwide regulatory requirement and business needs.
• Ensures product registrations are obtained and maintained as required.
• Functions as the RA voice of the country on applicable project teams. Where necessary, develop local documentation for product submissions based on specific country level regulatory requirements, to include the translation of applicable reports, labels, or other documents needed for submissions.
• Ensures that required Align, Suppliers and Distributors licenses/permits/certificates and KGMP certification needed to conduct business have been obtained and are maintained accordingly.
• Ensures continuous supply with internal & external regulatory compliance through on-time regulatory action such as product license variation, KGMP re-certification, MFDS re-evaluation and product license renewal.
• Review the GRP/GRIA on the new products and/or change plan for existing products, check Korea regulatory requirements, perform regulatory assessment, and provide the correct Korea regulatory requirements so that they can be reflected in the global plan.
• Review ad & promotional materials and provide a regulatory guidance according to global policy and local regulatory requirements as a regulatory reviewer.
• Assess and review PSAs, including locally occurring adverse event reports, and report in a timely in accordance with regulatory requirements.

In this role, you’ll need … 

• Knowledge of regulatory requirements for medical devices, including product registration and regulatory compliance practice from country scope.
• Experience in performing regulatory functions (e.g., writing submissions, reviewing documentation for regulatory compliance, interfacing with regulatory agencies, etc.) and medical device, KC, software-related regulatory requirements.
• Ability to work cross-functionally with multiple projects and communicating issues.
• Ability to execute project/program tasks with general supervision and little guidance.
• More than 5-8 years of experience in RA role at medical device company is required.

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.   

By joining Align, you will be part of a global, fast-growing company in one of the most dynamic industries. Great people, innovative technologies, and meaningful work – these are just some of the things employees say make Align Technology a great place to work.   

We respect your privacy. Please review our Applicant Privacy Policies for additional information.   

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

It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire.

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