Regulatory Affairs Executive

Role & responsibilities

• Lead global regulatory projects to secure market authorization and promotional approval for medical devices and pharmaceutical products.
• Collaborate closely with product development teams, including engineering, marketing, clinical investigations, and regional regulatory experts.
• Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines.
• Identify and define product testing and clinical study requirements to support regulatory submissions.
• Analyze and organize scientific data to demonstrate the safety and efficacy of medical devices.
• Prepare and submit regulatory documentation to authorities across global markets including the Australia, Singapore, Thailand, and Malaysia.
• Provide regulatory guidance throughout the product development lifecycle to ensure compliance with international standards.
• Evaluate design changes and determine licensing or registration needs.
• Review and approve promotional materials to ensure alignment with regulatory claims.
• Monitor regulatory trends and communicate new requirements to internal teams.

Required Qualifications

• Advanced experience in Regulatory Affairs, ideally within the medical device industry and pharmaceutical products, or advanced experience in product development within the medical device industry.
• Bachelor s degree from an accredited university or college, or equivalent relevant experience.
• Strong analytical, problem-solving, and project management skills.
• Excellent oral and written communication abilities.
• Proficiency in English (written and spoken).

Preferred Qualifications

• Experience interacting with global regulatory agencies (e.g., FDA, Notified Bodies, NMPA).
• Knowledge of Quality Management Systems (QMS) and regulatory compliance frameworks.
• Proven ability to work independently in a fast-paced, dynamic environment.
• Adaptability to change and capability to drive positive transformation.
• Excellent team orientation and responsiveness to customer needs.
• Detail-oriented with a focus on delivering results.
• Experience working in multicultural and cross-functional teams.

Bangalore