- Represent Align's policy interests in India and other South Asian countries.
- Ensure compliance with Indian medical device regulations for pre and post-market activities.
- Develop and implement regulatory strategies for local submissions and registrations.
- Collaborate with Corporate RAQA and R&D; program teams for design input and regulatory assessments.
- Monitor changes to regulations and policies, proactively identifying business impact issues.
- Provide administrative support to the Director, International Regulatory Affairs, APAC.
- Conduct post-market obligations and coordinate with APAC RAQA and U.S. headquarters for timely reporting and closures of adverse events/FSCA/recalls.
- Propose and coordinate position development of Align and assist with the lobbying strategy in India, establishing solid discussion channels and developing relationships with local government officials.
- Lead drafting of industry standards relevant to Align's product portfolio through participation in Industry associations.




- Assist with all department projects as required and participate in proactive team efforts to achieve departmental and company goals.
- Support audit processes and quality management system as needed.

Job Requirements
- Proficient in English and local language.
- Positive understanding of regulatory requirements for medical devices in India.
- Excellent written, verbal, and interpersonal communication skills.
- Ability to maintain constructive relationships with individuals at all organizational levels.
- Strong commitment to excellence and high standards of integrity, professionalism, loyalty, honesty, respect, openness, and business ethics.
- Ability to work independently and handle both small and large matters effectively.
- Bachelor's 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 a medical device company.
- Thorough understanding of India's med

📌 Regulatory Affairs Manager (New Delhi)
🏢 Align Technology
📍 New Delhi