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Urgently Require Sr.Regulatory Officer
Job Description:

1. Co-ordination and Preparation of necessary documentation and reports for Medical Device technical files, and                 operation of the file review and maintenance system. 

2. Compliance activities for the Medical Device Product. Indian and International .

3. Regulatory participation in Medical Device project work and Notified body audits when necessary. 

4. To support QA,helping to ensure that our ISO 13485 accreditation is maintained.

5. To maintain a knowledge and familiarity with current regulatory for all aspects of the job.

6. To support the Regulatory Team Leader in the reporting and analysis of the departmental performance.

7. To attend as required appropriate industry regulatory meeting, also self-learn.


      Experience Required:

  • Degree in Life Science or equivalent.
  • Prior experience within a regulatory function covering Medical Device, minimum 2 years working knowledge ISO 13485 regulation.
  • Proficiency in MS Word,Excel, and Power Point etc. would be preferred.
  • Good attention to detail
  • Excellent Communication skills
  • Analytical and numeracy skills

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