Caldor Health Technologies is hiring for the position of Quality & Regulatory Associate in Coimbatore, Tamil Nadu. This opportunity is suitable for candidates with 0–3 years of experience who want to build a career in medical device quality assurance and regulatory affairs.

The Quality & Regulatory Associate will work closely with R&D, engineering, clinical and management teams. The role provides hands-on exposure to ISO 13485 Quality Management Systems, CDSCO regulatory submissions, Design History Files (DHF), technical documentation and ISO 14971 risk management throughout the medical device development lifecycle.

Candidates from Biomedical, Biotechnology, Life Sciences, Mechanical and Electronics backgrounds can apply.

Key Responsibilities

As a Quality & Regulatory Associate at Caldor Health Technologies, responsibilities may include:

• Prepare, maintain and control ISO 13485 QMS documentation.
• Support CDSCO regulatory submissions and ongoing regulatory compliance activities.
• Prepare and maintain Design History Files (DHF), Device Master Files (DMF) and technical files.
• Assist with medical device risk management activities according to ISO 14971.
• Maintain design, development and product documentation.
• Support internal and external quality audits.
• Ensure appropriate documentation, traceability and document control.
• Coordinate with R&D, engineering, clinical and management teams.
• Support quality and regulatory activities from medical device R&D through regulatory approval and commercialization.

Eligibility & Qualifications

Candidates with an educational background in the following areas may be considered:

Biomedical Engineering | Biotechnology | Life Sciences | Mechanical Engineering | Electronics Engineering or related disciplines

Applicants should ideally have:

• 0–3 years of relevant experience.
• Strong attention to detail and documentation skills.
• Interest in medical device quality assurance and regulatory affairs.
• Basic understanding of quality systems and regulatory documentation.
• Ability to collaborate with multidisciplinary technical and clinical teams.

Candidates with knowledge of ISO 13485, ISO 14971, CDSCO medical device regulations, DHF, DMF, technical documentation, audits or design controls may have an advantage.

Why Consider This Opportunity?

This Quality & Regulatory Associate role provides an opportunity to gain practical exposure to the complete medical device lifecycle. Selected candidates can work alongside R&D, engineering, clinical and leadership teams while contributing to quality and regulatory activities associated with innovative medical devices.

The position can be particularly relevant for early-career professionals seeking experience in medical device regulatory affairs, quality assurance, ISO 13485 QMS, CDSCO compliance and medical device documentation.

Job Details

How to Apply

Interested and eligible candidates can send their updated resume directly to:

Email: management@caldorhealthtech.com