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.
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About this opportunity
The APAC Regulatory Affairs and Quality Assurance Department has a position in India for a Regulatory Affairs (RA) Manager to support these local & regional functions of the Department. The role is to oversee and focus on regulatory submissions, government advocacy, and post market activities in India
to help meet Align’s Regulatory goals to ensure that business processes in India are in full compliance with local medical device regulations and Align’s internal requirements. This Manager role needs to provide oversight on the guidance and recommendations to India’s business stakeholders and exporting countries stakeholders on India’s requirements and ensure compliance to accepted practices. This position is also responsible for developing regulatory strategies for local submissions and registrations in India, local post market compliance, 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 India’s CDSCO and other applicable regulatory agencies and to ensure relationship building.
This position is based in Align’s New Delhi office and has a solid line reporting to the Director, International Regulatory Affairs, APAC. The APAC corporate HQ is located in Singapore.
In this role, you will…
Regulatory Affairs
- Represent Align’s policy interests in India and other South Asian countries (e.g. Pakistan, Bangladesh, Sri Lanka, Nepal, Bhutan) as agreed with APAC RAQAGA Department, the site leadership team and U.S. headquarters.
- Responsible for ensuring the India sites comply with India’s medical device regulations for pre and post market; to conduct impact assessment, develop rationale and documentation for new product and product changes.
- Develop India’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 India’s CDSCO and/or notified bodies and/or applicable regulatory agencies 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 post market RA assessment & timely reporting and closures of adverse events/FSCA/recalls, locally.
- Monitor changes to regulations and policies and proactively identify issues that may have a business impact or of interest to Align, propose action plans to APAC RAQA and see through agreed plans.
- Propose and coordinate position development of Align and assist with the lobbying strategy in India.
- Establish a solid discussion channel and further develop relationships with local government officials in India.
Take a lead role in drafting of industry standards relevant to Align Technology’s product portfolio through participation in Industry associations.
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Others
- Provide administrative support to Director, International Regulatory Affairs, APAC,
- 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 …
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Proficient in English and local language
- Must have good understanding and grasp of the regulatory requirements for medical devices in India.
- 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
- 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.
- Minimum 6-10 years of experience in Regulatory Affairs covering pre and post market and Government Affairs role at medical device company is required.
- Thorough understanding of India’s medical device laws and regulations.
- 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 India’s CDSCO.
- Experience in performing Post Market action inclusive of FSCA and recalls to comply with local requirements.
- Able to build and maintain relationships with decision and policy makers within the India government.
- Excellent knowledge of India’s 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
Invisalign clear aligners, iTero Intraoral scanners, and Exocad digital services that help dental professionals achieve the clinical results they expect and deliver effective, cutting-edge dental options to their patients.
Your growth and well-being:
At Align, every smile matters. We’re committed to helping you thrive by supporting the health, growth, and well-being of our team members through a variety of tools and programs. While specific offerings may vary by location and role, Align employees can typically expect:
- Health and well-being programs to keep you thriving in both body and mind.
- Employee-exclusive discounts on Invisalign products.
- Learning opportunities through online learning resources and support for your individual development plans.
- Inclusive, global workplace that fosters collaboration, recognition and belonging.
Country and/or role specific details will be shared with you by your recruiter during the interview process.
Discover Align:
We are a global community of game-changers and smart team players, united by our belief in the power of a smile. Our dynamic team of exceptional employees is dedicated to transforming the industry and creating extraordinary outcomes every day.
Align’s core values of agility, customer, and accountability are more than words to work by, they are words we live by. The actions we take every day speak to who we are as a company and our focus on being truly impactful. We celebrate our differences, and the many ways we support one another— ultimately creating a more inclusive organization and world as we continue transforming smiles and changing lives.
We foster a culture where thinking differently and seeking new experiences are not just encouraged but celebrated. With the Align Mindset, we empower each other, ensuring every voice is heard and valued in an inclusive environment that inspires creativity and collaboration.
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 are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. 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.
As part of our commitment to innovation, Align Technology includes exocad and Cubicure, companies that enhance our offerings and extend our impact to industry transformation.
Eager to learn how we embrace our global differences and nurture employee well-being?
Explore Align's culture here!
Want to discover more about exocad and Cubicure? Click on their names for additional information.
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Equal Opportunity Statement:
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.
