Executive - QA and Ra (Level I/ Ii)

1 week ago

Vadodara Gujarat, India OrthoHeal Full time

JOB ID: 240204 Job family Regulatory

Job Type Full Time Location Vadodara, Gujarat Nature of Work On-site Company Name JC OrthoHeal Private Limited

**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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