Executive – QA and RA (Level I/ II)

JOB ID: 240204 Job family Regulatory
Position Title Executive – QA and RA (Level I/ II) Job Type Full Time
Location Vadodara, Gujarat Nature of Work On-site
Company Name JC OrthoHeal Private Limited Updated on 15.02.2024

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.

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