QARA Executive

We are looking for a Quality Assurance & Regulatory Affairs (QARA) professional with 13 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.

Key Responsibilities
Quality Management System (QMS)

• Maintain and support the companys 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.

• 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.

• Bachelors degree in Engineering Life Sciences Biomedical Pharmacy Biotechnology or related field.

• 13 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.

• ISO 13485

• Medical Device QMS

• Document Control

• CAPA / NCR / Complaint Handling

• Technical Documentation

• Risk Management

• Regulatory Affairs

• Attention to Detail

• Cross-functional Coordination

• Microsoft Office / Documentation Tools
  
  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