Quality Assurance & Regulatory Affairs Executive - Medical Devices

Why This Role Matters

In the medical device industry, regulatory compliance and quality assurance are directly linked to patient safety and product reliability. Medical devices must meet stringent global regulatory requirements before they can be marketed and must continue to comply throughout their lifecycle. Any lapse in documentation, quality controls, or regulatory alignment can lead to product recalls, market suspensions, or compliance risks.
This role plays a critical part in maintaining an effective Quality Management System (QMS) and ensuring adherence to global regulatory frameworks such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and CDSCO requirements. By supporting regulatory submissions and quality oversight from development through post-market surveillance, this position ensures that products remain compliant, safe, and market-ready.

Job Description

We are seeking a Quality Assurance & Regulatory Affairs Executive to support and execute quality and regulatory activities for medical devices. The role involves maintaining compliance with international medical device regulations and supporting the effective operation of the Quality Management System (QMS).
Reporting to the Head of Quality & Regulatory Affairs, the candidate will collaborate with cross-functional teams including R&D, Manufacturing, and Operations to ensure compliance throughout the product lifecycle—from development and validation to post-market activities.
The ideal candidate should have a strong understanding of medical device regulatory frameworks, documentation practices, and quality standards.

Key Features of the Role

• Involvement in end-to-end product lifecycle compliance
• Direct exposure to global medical device regulations
• Hands-on experience with QMS implementation and maintenance
• Cross-functional coordination with multiple departments
• Participation in regulatory submission preparation
• Opportunity to support audit and inspection readiness

Responsibilities

• Support the implementation and maintenance of the Quality Management System (QMS)
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and CDSCO regulations
• Assist in preparation and compilation of regulatory submissions for medical devices
• Support product registration and regulatory documentation updates
• Coordinate with cross-functional teams to collect technical and quality documentation
• Maintain quality records, SOPs, and regulatory documentation systems
• Assist in internal audits and support external audit readiness
• Monitor regulatory updates and implement necessary compliance changes
• Support post-market surveillance activities and complaint handling documentation
• Participate in risk management and design control documentation activities
• Ensure timely execution of regulatory and quality deliverables

Required Qualifications

• Strong understanding of medical device regulatory frameworks
• Knowledge of ISO 13485 and global quality management systems
• Familiarity with FDA 21 CFR Part 820 and EU MDR requirements
• Understanding of CDSCO regulations for medical devices
• Experience preparing regulatory submission dossiers
• Strong documentation and analytical skills

Educational Requirements

• M.Sc / B.Sc / B.Pharm / Engineering degree in relevant field
Candidates from life sciences, biomedical, pharmaceutical, or related engineering backgrounds are encouraged to apply.

Experience and Skills

• Minimum 3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry
• Experience supporting regulatory submissions and product registrations
• Strong knowledge of QMS processes and documentation practices
• Experience handling audits and regulatory inspections preferred
• Ability to work cross-functionally with technical and operational teams
• Strong written and verbal communication skills
• Detail-oriented with strong problem-solving ability
• Ability to manage multiple tasks within defined timelines
• Familiarity with risk management and design control processes

Salary Insights

Compensation: Up to ₹4,00,000 per year
Salary is aligned with industry standards for mid-level Quality & Regulatory professionals in the medical device sector. Final compensation depends on experience, regulatory exposure, and technical expertise.

Benefits include:
• Food provided
• Health Insurance
• Provident Fund

Company Overview

The organization operates within the medical device sector and is committed to maintaining high-quality standards and regulatory compliance across global markets. With a structured Quality Management System and strong regulatory framework, the company supports product development and commercialization in line with international standards.
The work culture emphasizes compliance excellence, teamwork, continuous learning, and adherence to patient safety principles.

FAQs

1. Is medical device industry experience mandatory?
Yes, prior experience in the medical device sector is strongly preferred.

2. Does this role involve regulatory submissions?
Yes, preparing and supporting regulatory submissions is a key responsibility.

3. Is ISO 13485 knowledge required?
Yes, strong knowledge of ISO 13485 and QMS implementation is essential.

4. Are FDA and EU MDR experience necessary?
Familiarity with FDA 21 CFR Part 820 and EU MDR regulations is highly preferred.

5. Is relocation required?
Preference is given to candidates from Davanagere, Chitradurga, or Haveri regions.

Application Tips

• Highlight your experience with ISO 13485 and QMS maintenance
• Mention regulatory submissions handled (FDA, EU MDR, CDSCO, etc.)
• Emphasize audit support and inspection readiness experience
• Showcase cross-functional coordination examples
• Quantify compliance improvements or quality initiatives supported