Job Description

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 Manager, Southeast Asia is responsible for driving regulatory submissions and post market activities (AE reporting, FSCA etc) in Southeast Asia with a focus on the following markets: Singapore, Malaysia, Indonesia, Vietnam, and Philippines. The position also monitors changes to applicable laws and legislations that could affect the organization in Southeast Asia and provides guidance to the site leadership team on matters relating to regulatory,. This position is based in Align\'s Singapore office and reports directly to the Director, Regulatory Affairs and Government Affairs, APAC, in the APAC corporate HQs located in Singapore with a dotted line to the Managing Director for Southeast Asia.

In this role, you will\xe2\x80\xa6

Essential duties include but are not limited to the following:

• Develop regulatory strategies, templates and documentation for product registrations for each new or modified product.
• Manage assigned product registration and licensing activities in accordance with the local regulations; including filing determinations and submission content.
• Compile information from multiple sources (e.g., project teams, corporate RA/QA, etc.) for submissions, guiding project teams in creating documentation for submissions, writing summaries and other necessary documentation for submissions.
• Assist with product safety determinations and vigilance reporting activities.
• Support product corrections and removals as directed by Corporate.
• Interface with regulatory agencies on regulatory issues.
• Assist management in planning regulatory activities, identifying road blocks, strategizing on various regulatory paths for new products and complying with regulations.
• Support sites CAPA activities including: investigation, root cause analysis, propose implementation plans, and effectiveness verification.
• Monitor changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align. Work collaboratively with site process owners to define improvements.
• Lead and/or assist project teams in Risk Management activities.
• Assist personnel with Engineering/Document Change requests. Partner with Marketing to ensure the integrity of packaging, labeling, and promotional materials. Ensure integrity of site quality records.
• Provide support to audit processes and quality management system as required
• Travel may be required - up to 20%.

Additional Responsibilities: Other duties may be assigned

Managing document updates, change requests and quality incidents/CAPA processes in electronic document control system.

Others

• Managing and tracking of regulatory/quality consultant contracts.
• Purchase requisition/purchase order creation for new consultants.
• Due diligence processes for new consultants.
• Maintenance of approval databases.
• Monthly KPI database update.
• Collating GRIA replies from local APAC markets for Director, APAC RA, to review.
• Updating sharepoint with final APAC GRIA.

Any other administrative/adhoc duties as required.

In this role, you\'ll need \xe2\x80\xa6

• 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.
• Ability to balance between the growth needs of the company and the stringent compliance requirements associated with the healthcare services delivered by the company while ensuring compliance with the Standards of Conduct and all applicable laws and regulations.
• 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.
• Bachelor Degree in Science or Engineering preferred.
• 6-10 years of experience in Regulatory and Quality Assurance role at medical device company is required.
• Thorough understanding of Southeast Asia 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.
• Ability to research and propose well - thought out solutions when dealing with challenges.

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.

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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