Regulatory Affairs Manager, India & South Asia

About this opportunity

The International Regulatory Affairs 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 will work under and closely support the India and SEA RA Lead. This role has a solid line reporting to the Director, International Regulatory Affairs, APAC. Both the India and SEA RA Lead and Director, International Regulatory Affairs, APAC are based in the APAC corporate HQ. The APAC corporate HQ is located in Singapore.

Role expectations

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.

Others

• Provide administrative support to Director, International Regulatory Affairs, APAC,

• Provide RA support for South East Asia markets where needed

• 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.

What we're looking for

• 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.