Executive – QA and RA (Level I/ II)

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Executive – QA and RA (Level I/ II)

Summary:

Executive (QA, RA) (Level I/ II) will work with the regulatory team and formulate or implement regulatory affairs policies and procedures.

Key Roles and Responsibility

• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Develop or compile all the necessary documents required for the regulatory submissions.
• Maintain the device registration status and ensure timely re-registration.
• Assist in providing support to the local and international distributors to register devices when required.
• Collect and analyze data of Legal and Regulatory requirements including mandatory label marking requirements.
• Assist in training staff in regulatory policies or procedures.
• Participate in the development or implementation of clinical trial protocols.
• Supports post market surveillance and vigilance activity when it is required.
• Maintain and upkeep of all regulatory information, technical file, licenses, and certificates.
• Draft applicable QMS procedures and formats as per ISO 13485 in the organization.
• Manage change control activities.
• Ensure the effectiveness of the quality management system.
• Set and track quality assurance goals.
• Documentation and Record keeping.

Skills and Qualifications

• Education: Graduation / Post Graduate in Science.
• Skill & Knowledge.
• Basic computer skills.
• Able to work in a strict timeline.
• Strong organizational and persuasive skills.
• Good verbal and communication skills.