Caldor Health Technologies Hiring Quality & Regulatory Associate | Freshers & Experienced Candidates Can Apply
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(Caldor Health Technologies Hiring Quality & Regulatory Associate) |
Introduction
Caldor Health Technologies has announced an excellent career opportunity for candidates interested in Medical Device Quality Assurance and Regulatory Affairs. The company is currently hiring for the position of Quality & Regulatory Associate at its Coimbatore location.
This opportunity is suitable for fresh graduates as well as professionals with up to 3 years of experience who want to build a career in medical device compliance, quality systems, regulatory documentation, risk management, and product lifecycle management.
Professionals interested in ISO 13485 Quality Management Systems, CDSCO regulations, Design History Files (DHF), Device Master Files (DMF), and medical device regulatory submissions may find this role highly valuable for long-term career growth.
About Caldor Health Technologies
Caldor Health Technologies is an emerging medical device and healthcare technology company focused on developing innovative healthcare solutions and advanced medical technologies. The organization works at the intersection of engineering, healthcare, quality systems, and regulatory compliance to bring safe and effective medical products to market.
The company supports product development activities from concept and design through regulatory approval and commercialization. By maintaining strong quality standards and regulatory compliance practices, Caldor Health Technologies aims to contribute to the growing medical device and healthcare innovation ecosystem.
Headquarters: Coimbatore, Tamil Nadu, India
Industry: Medical Devices and Healthcare Technology
Founded: Information not publicly specified by the company
Employees: Not officially disclosed
Job Overview Summary
The Quality & Regulatory Associate position provides an opportunity to work closely with multidisciplinary teams involved in medical device development, quality assurance, regulatory affairs, documentation control, and compliance activities.
The selected candidate will support quality management systems, regulatory submissions, technical documentation, risk management processes, and audit activities while gaining practical exposure to the complete medical device lifecycle.
This role is particularly suitable for candidates seeking careers in Medical Device Regulatory Affairs, Medical Device Quality Assurance, CDSCO Compliance, ISO 13485 Systems, and Healthcare Technology Compliance.
Vacancy Details
| Particular |
Details |
| Company |
Caldor Health Technologies |
| Position |
Quality & Regulatory Associate |
| Location |
Coimbatore, Tamil Nadu |
| Employment Type |
Full-Time |
| Work Mode |
In-Person |
| Experience |
0–3 Years |
| Industry |
Medical Devices / MedTech |
| Department |
Quality & Regulatory Affairs |
| Key Areas |
ISO 13485, CDSCO, DHF, DMF, ISO 14971, QMS |
Job Role Explanation
As a Quality & Regulatory Associate, the selected professional will support quality and regulatory functions across various stages of medical device development.
The role involves maintaining documentation, ensuring compliance with regulatory requirements, supporting quality management systems, and collaborating with technical teams to ensure product quality and regulatory readiness.
Candidates will gain exposure to medical device regulations, quality standards, documentation practices, audit processes, and risk management methodologies commonly used in the healthcare and medical device industry.
Key Responsibilities
The selected candidate may be responsible for:
- Maintaining ISO 13485 Quality Management System documentation.
- Supporting CDSCO medical device regulatory submissions.
- Preparing and maintaining Design History Files (DHF).
- Managing Device Master Files (DMF).
- Supporting technical documentation preparation.
- Assisting in ISO 14971 risk management activities.
- Maintaining product development documentation.
- Supporting design control documentation.
- Participating in internal quality audits.
- Assisting during external audits and inspections.
- Ensuring proper document control and traceability.
- Collaborating with R&D, engineering, clinical and management teams.
- Supporting regulatory compliance throughout the product lifecycle.
- Assisting with commercialization-related compliance activities.
Eligibility Criteria
Candidates should possess qualifications in one of the following disciplines:
- Biomedical Engineering
- Biotechnology
- Life Sciences
- Mechanical Engineering
- Electronics Engineering
- Related Scientific Disciplines
Experience Requirement
- 0–3 Years of relevant experience
Fresh graduates with strong academic backgrounds and an interest in quality and regulatory functions may also be considered.
Skills Required
The company is looking for candidates with strong documentation and compliance capabilities.
Preferred skills include:
- ISO 13485 Quality Management Systems
- CDSCO Medical Device Regulations
- ISO 14971 Risk Management
- Design Controls
- Regulatory Documentation
- Medical Device Compliance
- Technical File Preparation
- Design History Files (DHF)
- Device Master Files (DMF)
- Audit Support
- Quality Assurance
- Document Control
- Traceability Management
- Medical Device Lifecycle Knowledge
- Communication Skills
- Team Collaboration
Knowledge of medical device standards and regulatory frameworks can provide a competitive advantage.
Salary Estimate
Caldor Health Technologies has not officially disclosed the salary package for this position.
Based on similar Medical Device Quality Assurance and Regulatory Affairs roles in India, the estimated salary range may be:
₹3.0 LPA – ₹6.5 LPA
Actual compensation may vary depending on qualifications, technical knowledge, certifications, interview performance, and prior experience.
Interview Details
The company has not released specific interview information.
Candidates can generally expect:
Selection Process
- Resume Screening
- HR Discussion
- Technical Interview
- Quality & Regulatory Assessment
- Final Management Discussion
The final selection process may vary according to company requirements.
Required Documents
Candidates should keep the following documents ready before applying:
- Updated Resume/CV
- Educational Certificates
- Internship Certificates (if applicable)
- Experience Certificates (for experienced candidates)
- Government ID Proof
- Passport Size Photograph
- Technical Certifications
- Latest Salary Documents (if applicable)
Why Consider This Opportunity?
This position provides valuable exposure to:
- Medical Device Regulatory Affairs
- Medical Device Quality Assurance
- CDSCO Compliance
- ISO 13485 Quality Systems
- ISO 14971 Risk Management
- Product Lifecycle Management
- Design Controls
- Regulatory Documentation
- Audit Readiness
- Healthcare Technology Compliance
Professionals interested in building a long-term career in the Medical Device Industry can gain strong practical experience through this role.
How to Apply
Interested and eligible candidates can send their updated resume directly to:
Email: management@caldorhealthtech.com
Candidates should ensure that their resume clearly highlights relevant educational qualifications, technical knowledge, internships, certifications, and any experience related to quality assurance or regulatory affairs.
Frequently Asked Questions (FAQs)
Is this position suitable for freshers?
Yes. Candidates with 0–3 years of experience can apply, making it suitable for fresh graduates and early-career professionals.
Which educational backgrounds are eligible?
Biomedical Engineering, Biotechnology, Life Sciences, Mechanical Engineering, Electronics Engineering, and related disciplines are eligible.
Is prior regulatory affairs experience mandatory?
No. While relevant experience is beneficial, candidates with strong academic knowledge and interest in regulatory affairs may also be considered.
What standards are important for this role?
ISO 13485, ISO 14971, CDSCO regulations, Design Controls, DHF, and DMF are important areas of knowledge.
What career growth opportunities are available?
This role can lead to careers in Regulatory Affairs, Quality Assurance, Medical Device Compliance, Product Quality Management, and Regulatory Strategy.
Final Conclusion
The Caldor Health Technologies Quality & Regulatory Associate opportunity offers an excellent starting point for professionals interested in Medical Device Regulatory Affairs and Quality Assurance. With exposure to ISO 13485 systems, CDSCO regulations, risk management, technical documentation, and product lifecycle compliance, the role provides valuable industry experience for long-term career development.
Candidates from Biomedical Engineering, Biotechnology, Life Sciences, Mechanical Engineering, and Electronics backgrounds who wish to establish themselves in the growing Medical Device and Healthcare Technology sector should consider applying for this opportunity.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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