Location: New Delhi
Department: Quality Assurance & Regulatory Affairs
Reporting To: DGM Manufacturing
Experience: 1-2 years

Company Description

Cosmic MedTech Solutions Pvt Ltd is an innovative startup driven by a team with over 20 years of industry expertise. Guided by the mission, “Advancing Humanity Through Innovative Care,” we are dedicated to strengthening India’s healthcare landscape by making accessible and affordable solutions a reality. Our focus lies in accelerating technology adoption, bridging critical gaps, and ensuring quality care reaches every corner of the nation.

Our mission is to revolutionise healthcare by creating sustainable, transformative, and technology-driven pathways. We are dedicated to elevating the standard of care by making advanced medical technology accessible. Beyond shaping the future of healthcare in India and South Asia, we are committed to cultivating the next generation of leaders and innovators—driven by resilience, equity, and purpose. We are a collaborative, values-driven team looking for a dynamic and visionary professional to lead and grow our quality assurance and regulatory affair initiatives.

Position Summary

The QA/RA Manager will lead all quality and regulatory functions, ensuring compliance with ISO 13485, ISO 9001, and global regulatory requirements for our IVD manufacturing facility. This key leadership role will oversee regulatory affairs, quality assurance, quality engineering, validation, final batch release, documentation control, and incoming inspections.

Key Responsibilities:

• Act as a management representative for ISO 9001 and ISO 13485 certifications.
• Maintain and control the quality manual and related documentation.
• Organise and report on management reviews and quality system performance.
• Manage product review and release processes, including Certificates of Conformity.
• Oversee change control, document control, batch documentation, and final label approvals.
• Coordinate and host regulatory inspections (e.g., FDA and ISO audits) and supplier audits.
• Ensure equipment, process, and software validations meet regulatory standards.
• Manage Non-Conformance, CAPA systems, Product Recalls, and Medical Device Reporting (MDR).
• Support regulatory submissions (e.g., FDA, CDSCO) and ensure global compliance.
• Actively participate in Design Control and continuous improvement initiatives.
• Drive quality awareness and compliance across all departments.
• Ensure strict adherence to Health, Safety, and Environmental regulations.

Education and Experience:

• Bachelor’s degree in Science, Engineering, or Business, or equivalent operational experience.
• Minimum 2+ years’ industrial experience in IVD or a related medical device industry.
• Hands-on experience in regulatory inspections (ISO/FDA) and hosting audits.
• Strong project management skills, especially in change management programs.
• Proven success in training delivery, team leadership, and quality system implementation.

Skills and Behaviors

• • Logical, structured, and proactive approach to problem-solving.
  • Excellent verbal, written, interpersonal, and presentation skills.
  • Deep understanding of ISO standards, GLP, GMP, and global regulations.
  • Strong project management and cross-functional collaboration skills.
  • High attention to detail with a balanced cost-quality-customer mindset.
  • Ability to work under pressure, make objective decisions, and influence teams.
  • Passion for continuous learning, development, and organizational improvement.

Why Join Us?

Join a dynamic startup environment where your expertise will directly shape a new state-of-the-art IVD manufacturing facility and drive healthcare innovation across South Asia.