QA/RA Sr. Executive - Medical Devices

Job Description:

Quality Assurance

• Administration, training, and auditing of Quality System Tools (Customer Complaints, CAPA, Training, Control Documents, Standards).
• Ensure compliance of quality procedures and work instructions with applicable standards.
• Conduct audits, training, preventive and corrective actions to maintain the QA system.
• Maintain training, qualification, and certification records of personnel.
• Approve/disapprove suppliers, vendors, facilities, equipment, processes, and materials as per Quality Manual.

Regulatory Affairs

• Manage regulatory submissions in various countries.
• Provide regulatory support across company functions.
• Define and conduct tests/bench tests for regulatory compliance.
• Review and approve marketing, social media, and labeling materials.
• Report directly to QA Director.

Experience Required:

• Hands-on experience in Medical Devices with implementation of QMS.
• Regulatory submissions as per ISO 13485, FDA, CE (MDD/MDR), and MEDDEV.
• Drafting/maintaining SOPs, following GLP/GMP requirements.
• Experience in internal & external audits/inspections.

Preferred Skills:

• ERP (Priority) and ALM (Orcanos) systems.
• Strong English communication skills (verbal & written).
• Independent, self-motivated, and proactive working style.
• Strong planning, organizational and interpersonal skills.
• Technical knowledge and adaptability.