Align Technology
Regulatory Affairs Specialist - Contractor
Align Technology, San Jose, California, United States, 95199
Regulatory Affairs Specialist - Contractor
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- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. This role requires strong organization, written and oral communication skills, and must be able to perform tasks with accuracy and a high attention to detail. Duration is 6 months with possible extension. This position will be based in San Jose, CA. In this role, you will… Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory filing like a 510(k) or Pre-submission or a new/amended Health Canada License application for a Class II new product and may include renewal of Licenses Support international regulatory filing Assist in streamlining or updating regulatory processes Assist in regulatory intelligence activities Assist in post-market surveillance activities, such as complaint handling and vigilance reporting Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance Perform other related assignments as required In this role, you’ll need … Bachelor’s degree in Science, Engineering, Regulatory, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving. Must be available to work with a hybrid schedule (3 days in office, 2 days remote) in office: San Jose, California 1-2 years experience in medical device industry. Experience of medical device, SaMD development, or regulatory affairs is preferred Knowledged of US regulation in medical device is required In-depth knowledge and skills with computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint Motivated and quick to learn new concepts and understand technical writing and medical device regulations Proficient written and oral communication skills Organized and detail-oriented Ability to manage work effectively in a remote capacity in a fast-paced, dynamic but often ambiguous workplace 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. About the company
Align Technology is a manufacturer of 3D digital scanners and the Invisalign clear aligners used in orthodontics. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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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- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance. This role requires strong organization, written and oral communication skills, and must be able to perform tasks with accuracy and a high attention to detail. Duration is 6 months with possible extension. This position will be based in San Jose, CA. In this role, you will… Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory filing like a 510(k) or Pre-submission or a new/amended Health Canada License application for a Class II new product and may include renewal of Licenses Support international regulatory filing Assist in streamlining or updating regulatory processes Assist in regulatory intelligence activities Assist in post-market surveillance activities, such as complaint handling and vigilance reporting Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance Perform other related assignments as required In this role, you’ll need … Bachelor’s degree in Science, Engineering, Regulatory, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving. Must be available to work with a hybrid schedule (3 days in office, 2 days remote) in office: San Jose, California 1-2 years experience in medical device industry. Experience of medical device, SaMD development, or regulatory affairs is preferred Knowledged of US regulation in medical device is required In-depth knowledge and skills with computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint Motivated and quick to learn new concepts and understand technical writing and medical device regulations Proficient written and oral communication skills Organized and detail-oriented Ability to manage work effectively in a remote capacity in a fast-paced, dynamic but often ambiguous workplace 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. About the company
Align Technology is a manufacturer of 3D digital scanners and the Invisalign clear aligners used in orthodontics. Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000. Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility. An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report . NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.
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