Regulatory Affairs Executive

  • icon job experience 0 - 6 Years
  • icon job opening 10 Openings
  • icon salary 8.0-17.0 Lac/Yr
  • icon job location Hyderabad
  • Face-to-Face interview Face-to-Face interview

Job Description

Part time job that you can continue with your existing job. We keep your details anonymous. 100% remote working

Knowledge of Implementing quality management system and regulatory strategies for maintaining compliance with established standards like ISO , ISO , US FDA and CE Marking.

Responsible for implementation of EU MDR related deliverables across product lines.

Actively participating in GAP analysis between MDD and MDR thereby identifying gaps in the current devices

Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)

Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV /1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.
  • Experience

    0 - 6 Years

  • No. of Openings

    10

  • Education

    Any Bachelor Degree

  • Role

    Regulatory Affairs Executive

  • Industry Type

    Hospitals / Medical / Healthcare Equipments

  • Gender

    [ Male / Female ]

  • Job Country

    India

  • Type of Job

    Part Time

  • Work Location Type

    Work from Office

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