Executive – Regulatory Affairs (Medical Devices)

  • Reporting to: Assistant Manager – Regulatory Affairs
  • Division: Ortho Implants
  • Location: Chennai
  • No. of Positions: 1
  • Education: B.E/ B. Tech in Biomedical Engineering / M. Pharm Regulatory Affairs
  • Experience: 2 – 4 years Exp. in ‘scientific writing / clinical documentation’ role preferred

 

KEY RESPONSIBILITIES:

  • Technical writing,  literature search, review, data extraction, Data Analysis and appraisal  as per guidelines for medical devices (Class III)
  • Scientific development and template preparation for protocols and procedures, related to ortho implant surgeries during piloting phase as well post-marketing surveillance studies.

 

DESIRED CANDIDATE PROFILE:

  • Experience in ‘scientific writing/clinical documentation’ role.
  • Exposure to medical device regulatory affairs, is preferable.
  • Proficiency in English, Proof reading skills and MS Office skills mandatory.
  • Knowledge of any other document/image editing software is a plus.
  • Possesses logical, analytical and verbal skills.