Executive (RA, QA) ( Level I/ II)
JC OrthoHeal Private Limited is looking for ‘Executive (RA, QA) ( Level I/ II)’ to grow our footprints.
| JOB ID: | OHRA250401 | Job family | Regulatory Affairs |
| Position Title | Executive (RA, QA) ( Level I/ II) | Job Type | Full Time |
| Location | Manjuser, Vadodara | Nature of Work | On-site |
| Company Name | JC OrthoHeal Private Limited | Updated on | 24.04.2025 |
OrthoHeal is a leading Med-Tech company specializing in orthopedic medical devices. The company focuses on improving post-operative orthopedic recoveries and innovating technologies to enhance patient care. OrthoHeal’s flagship product, FlexiOH®, is a cutting-edge orthopedic immobilization technology designed for comfort and effectiveness.
About the Role:
Executive (RA, QA) ( Level I/ II) will work with the regulatory team and Formulate or implement regulatory affairs policies and procedures.
Key Responsibilities:
- 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 analyse 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.
Qualifications:
- Education : Graduation/ Post Graduate in Science.
Skills:
- Basic computer skills.
- Able to work in a strict timeline.
- Strong organizational and persuasive skills.
- Good verbal and communication skills