Regulatory Affairs and Quality Assurance Manager, Taiwan and Hong Kong

Job content

Join a team that is changing millions of lives.

Transforming smiles. Transforming lives. Transforming an industry.

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 teams are constantly pushing the boundaries of what’s possible.

Ready to join us?

About this opportunity

The APAC Regulatory and Quality Assurance Department has a position in Taiwan for a Regulatory Affairs and Quality Assurance Manager to support Taiwan, Hong Kong and Macau RA, QA functions of the Department.  This role reports to APAC RAGA Director. The role is to oversee and focus on regulatory submissions and quality management system efforts in Taiwan, Hong Kong and Macau and to overall support the APAC RAGA Director & APAC RAQA Director in achieving the department goals from a local level, cascading to APAC level. This Manager role needs to provide oversight on the guidance and recommendations to other country business stakeholders on Taiwan, Hong Kong and Macau’s requirements and ensure compliance to accepted practices. This position is also responsible for developing Taiwan, Hong Kong and Macau’s regulatory strategies for local submissions and registrations, working in tandem with Corporate RAQA and R&D program teams for design input and regulatory assessments. Help to proactively drive Align’s agenda by engaging with Taiwan FDA, Hong Kong Department of Health and other applicable regulatory agencies and to ensure relationship building.

In this role, you will…

Regulatory Affairs

• Represent Align’s policy interests in Taiwan, Hong Kong and Macau as agreed with APAC RAQA Department, the site leadership team and U.S. headquarters.
• Responsible for leading the Taiwan and Hong Kong Office in complying with Taiwan and Hong Kong medical device regulations; to conduct impact assessment, develop rationale and documentation for new product and product changes.
• Develop Taiwan, Hong Kong and Macau’s regulatory strategies for local submissions and registrations, working in tandem with Corporate RAQA and R&D program teams for design input and regulatory assessments.
• Work collaboratively with APAC RAQA, project teams and U.S. headquarters, to prepare and submit regulatory submissions to the Taiwan FDA and Hong Kong Department of Health and/or notified bodies for new or change submissions.
• Ensure that annual or time limited product approvals/site licenses are renewed/maintained to ensure product supply.
• Conduct post market obligations and coordinate with APAC RAQA and U.S. headquarters to ensure timely reporting of adverse events.

Quality Assurance

• Responsible for developing and maintaining the site Quality System policies, procedures and quality records to comply with Global Align QMS cascaded form APAC and local Taiwan, Hong Kong & Macau QMS requirement. These include import documentation, training records, complaint handling records, CAPA, MR records etc. Assume the role of Management Representative of QMS, conducting QMR/RAQA Review annually, where applicable
• Develop and maintain site CAPA activities including: investigation, root cause analysis, propose implementation plans, and effectiveness verification.
• Coordinate with site personnel to ensure the success of local site audits in Taiwan, Hong Kong, Macau by local Authorities and internal Corporate audits including overseas Taiwan FDA site audits of manufacturing facilities
• Drive closure to audit findings including investigation, implementation, and effectiveness checks.
• Work collaboratively with process owners to define and execute quality improvement plans.
• Lead and/or assist project teams in Risk Management activities.
• Provide oversight on the guidance and recommendations to other country business stakeholders on Taiwan, Hong Kong and Macau’s requirements and ensure compliance to accepted practices.

Others

• Assist with all department projects as required.
• Participate in proactive team efforts to achieve departmental and company goals.
• Provide support to audit processes and quality management system as required.

In this role, you’ll need …

• Proficient in English, with a working knowledge of other APAC languages.
• Must understand the regulatory requirements for medical devices.
• Excellent written, verbal and interpersonal communication skills with demonstrated ability to effectively communicate with company personnel, consultants, and government officials.
• Ability to maintain constructive relationships with individuals at all levels within the organizations and influence without direct authority.
• A strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, open mindedness, open communication, respect, and business ethics
• As an individual contributor without direct reportees, must be able to work independently, and handle both small and large matters with equal effectiveness and enthusiasm.
• Must be able to thrive in a fast-paced environment with ever-changing business objectives, be willing to adapt to change, as well as being capable of driving change.

EDUCATION and/or EXPERIENCE

• Bachelor Degree in Science or Engineering preferred.
• 10-12 years of experience in Regulatory, Quality Assurance and Government Affairs role at medical device company is required.
• Thorough understanding of Taiwan and Hong Kong medical device laws and regulations.
• Extensive experience in performing all regulatory functions (e.g., writing submissions, reviewing documentation for regulatory compliance, interfacing with regulatory agencies, etc.) and medical device, software-related regulatory requirements.
• Significant experience within the legislative and regulatory fields applicable to medical devices, including interaction with government officials at the Taiwan FDA and Hong Kong Department of Health.
• Extensive experience in performing QMS functions to comply with local requirements.
• Demonstrated ability to ability to build and maintain relationships with decision and policy makers within the Taiwan and Hong Kong government.
• Excellent knowledge of the Taiwan and Hong Kong legislative and regulatory landscapes and processes.
• Ability to research and propose well-thought out solutions when dealing with challenges.

Sound like a good fit?

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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 ofchanging 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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