Safety Manager
JP-13-Shinagawa-ku
APAC | Japanese
Req #: 41455
Type: Regular Full-Time
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Overview: 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? In this role, you will ESSENTIAL DUTIES AND RESPONSIBILITIES * Identify and lead the implementation of continuous improvement (process and quality) focus on exceeding customer needs, especially simplification/improvements for post marketing activities. * Ensure post marketing activities based on the MHLW GVP/QMS Ordinance such as leading the implementation of safety measures, e.g. provide training, recall, stop shipment, report to health authorities, labeling update, preparation and distribution of safety information to medical personnel and distributors. * Coordinate all the preparation and hosting activities in internal/external audits relating to GVP and act as a Safety Manager at the Japan commercial office. * Communicate with manufacturers regarding product quality/services and encourage them to enhance their quality. * Work closely with global complaint handling team and Japan commercial team and build good relationships. * Responsible for the effective fulfillment of objectives and deadlines assigned. * Participate in team efforts to achieve departmental and organization goals. Additional responsibilities * Other duties may be assigned. In this role, you'll need QUALIFICATIONS * In depth knowledge of Quality System regulations - ISO 13485, MHLW QMS/GVP Ordinances and PMD Act. * Must interact well with all levels of management, co-workers, and regulators. * Good document practice including logical writing. * Interpersonal communication skills and work independently as well as in close collaboration with others. * Ability to do research and come up with creative, compliant solutions for quality challenges. * Demonstrated leadership; proven track of managing projects/people deploying planning, executing/validating and implementing phases. * Attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects. * Computer skills including Word and Excel. EDUCATION and/or EXPERIENCE * Bachelor degree is required; Engineering or Science preferred * Minimum 5 years working experience in Post marketing safety organization is required; preferably in medical device industry * Work experience in an American and/or European company is desired SKILLS REQUIRED: LANGUAGE SKILLS * Fluent English required (reading, writing, and conversation) * Excellent written and oral communications and ability to synthesize information to present internally as well as to regulatory agencies 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. Responsibilities: ABC Responsibilities Qualifications: ABC Quals
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