Senior QARA Executive

Oivi; Bengaluru; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Oivi in Bengaluru seeks a Quality Assurance Regulatory Affairs professional with 5+ years in the medical device industry to support QMS maintenance, regulatory documentation, and compliance.

You will manage document control, CAPA, NCR, risk management, and assist in regulatory submissions and UDI activities across applicable markets.

Collaborating with cross-functional teams and HR for training records, you will help ensure audits and regulatory updates are handled efficiently.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical, Pharmacy, Biotechnology, or related field.
• 5+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Mandatory experience working with International Organization for Standardization 13485 Quality Management Systems.
• Good understanding of document control, CAPA, NCR, complaint handling, and risk management processes.
• Experience in technical documentation and QMS documentation management.
• Experience in internal and external audit activities.
• Good communication and coordination skills.

Responsibilities

• Maintain and support QMS in compliance with ISO 13485 requirements.
• Prepare, review, update, and maintain QMS documents including SOPs, procedures, work instructions, forms, and templates.
• Ensure proper document and record control practices, including version control, traceability, archival, and obsolescence management.
• Perform document release checks and proofreading before release to ensure correct document numbering, revision status, formatting, and completeness.
• Support handling and closure of Customer Complaints, CAPA, NCR, deviations, change controls, and risk management activities.
• Monitor QMS performance metrics and support continuous quality improvement initiatives.
• Coordinate internal training activities along with HR and ensure training records are maintained.
• Coordinate with cross-functional teams to ensure completion and maintenance of quality records.
• Support internal audit and external audit activities.
• Assist design and development teams in preparation and review of design verification and validation documentation.
• Support preparation and maintenance of technical documentation and technical files for medical devices.
• Assess documentation gaps against applicable standards and regulatory requirements.
• Support risk management documentation activities as per applicable standards.
• Support regulatory submissions and product registrations in applicable markets.
• Maintain regulatory submission records, approvals, licenses, and related documentation.
• Monitor regulatory updates and assess their impact on existing products and processes.
• Support UDI compliance activities and maintenance of related records.
• Coordinate with regulatory authorities, notified bodies, consultants, and internal stakeholders as required.
• Assist in maintaining compliance with applicable medical device regulations and standards.

Skills

ISO 13485

Medical Device QMS

Document Control

CAPA / NCR / Complaint Handling

Technical Documentation

Risk Management

Regulatory Affairs

Attention to Detail

Cross-functional Coordination

Education

Bachelor's degree in Engineering, Life Sciences, Biomedical, Pharmacy, Biotechnology, or related field

Job description

We are looking for a Quality Assurance Regulatory Affairs (QARA) professional with 5+ years of experience in the medical device industry. The candidate will support the maintenance of the Quality Management System (QMS), regulatory documentation, technical documentation, and compliance activities in accordance with applicable regulatory requirements and standards.

Responsibilities

Quality Management System (QMS)

• Maintain and support the company's Quality Management System in compliance with International Organization for Standardization 13485 requirements.
• Prepare, review, update, and maintain QMS documents including SOPs, procedures, work instructions, forms, and templates.
• Ensure proper document and record control practices, including version control, traceability, archival, and obsolescence management.
• Perform document release checks and proofreading before release to ensure correct document numbering, revision status, formatting, and completeness.
• Support handling and closure of Customer Complaints, CAPA, NCR, deviations, change controls, and risk management activities.
• Monitor QMS performance metrics and support continuous quality improvement initiatives.
• Coordinate internal training activities along with HR and ensure training records are maintained.
• Coordinate with cross-functional teams to ensure completion and maintenance of quality records.
• Support internal audit and external audit activities.

Design Technical Documentation Support

• Assist design and development teams in preparation and review of design verification and validation documentation.
• Support preparation and maintenance of technical documentation and technical files for medical devices.
• Assess documentation gaps against applicable standards and regulatory requirements.
• Support risk management documentation activities as per applicable standards.

Regulatory Affairs Support

• Support regulatory submissions and product registrations in applicable markets.
• Maintain regulatory submission records, approvals, licenses, and related documentation.
• Monitor regulatory updates and assess their impact on existing products and processes.
• Support UDI compliance activities and maintenance of related records.
• Coordinate with regulatory authorities, notified bodies, consultants, and internal stakeholders as required.
• Assist in maintaining compliance with applicable medical device regulations and standards.

Required Qualifications Experience

• Bachelor's degree in Engineering, Life Sciences, Biomedical, Pharmacy, Biotechnology, or related field.
• 5+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Mandatory experience working with International Organization for Standardization 13485 Quality Management Systems.
• Good understanding of document control, CAPA, NCR, complaint handling, and risk management processes.
• Experience in technical documentation and QMS documentation management.
• Experience in internal and external audit activities.
• Good communication and coordination skills.

Key Skills

• ISO 13485
• Medical Device QMS
• Document Control
• CAPA / NCR / Complaint Handling
• Technical Documentation
• Risk Management
• Regulatory Affairs
• Attention to Detail
• Cross-functional Coordination

Nice to Have

• Exposure to:
  • U.S. Food and Drug Administration regulations
  • Central Drugs Standard Control Organization requirements
  • European Commission requirements
  • UDI compliance activities
  • Design control documentation

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.