India RAQA Director - Remote

Overview

The QARA Director for India will lead a team supporting Quality Assurance and Regulatory Affairs activities, ensuring compliance with Indian and international medical device regulations.

In Short

• Lead Quality Assurance and Regulatory Affairs (QA/RA) activities in India.
• Develop and implement regulatory strategies for timely product registrations.
• Collaborate with cross-functional teams to manage regulatory submissions.
• Maintain the Quality Management System in compliance with ISO 13485.
• Oversee audits and manage quality assurance programs.
• Drive continuous improvement initiatives.
• Provide leadership and mentorship to the QA/RA team.
• Engage with regulators and industry organizations.
• Translate regulations into effective business processes.
• Influence business performance through strategic decision-making.

Requirements

• 10-12 years of experience in Quality Assurance and Regulatory Affairs.
• Strong understanding of Indian Medical Device Rules.
• Proven leadership in managing audits and regulatory submissions.
• Excellent collaboration and communication skills.
• Strategic thinking capabilities.
• Bachelor’s or Master’s degree in Life Sciences or Engineering.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive plan eligibility.
• Commitment to employee development and resources.
• Culture of belonging and career-building support.