Regulatory Affairs Manager

• 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.
• Good 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 medical device laws and regulations.
• Experience in performing all regulatory functions, including writing submissions, reviewing documentation for regulatory compliance, and interfacing with regulatory agencies.
• 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 actions, including 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.
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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.

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