Title Senior Regulatory Affairs Associate

Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
HSIIDC, Sonepat-131028,
Haryana, India

Job Information
  • 5-8 yrs of working experience in Medical Device Regulatory Affairs
  • Knowledge of MDD 92/42/EEC & 21 CFR, Subchapter H
  • Knowledge of ISO 13485 & 21 CFR 820
  • Knowledge of all applicable medical device directives and FDA regulations on orthopedic implants, external fixators and surgical instruments.
  • Preparation of EU technical files.
  • Preparation of US regulatory submission files
  • Preparation of Clinical Evaluation Reports
  • Role in PMS & PMCF of devices
  • Review Labeling
  • Registration Dossiers and submissions in various countries other than EU region and US.
  • Provide Regulatory review of customer complaints
  • Ensure all regulatory requirement compliance on Design & Development team.
  • Work with regulatory affairs consultants when required.
  • Other duties & responsibilities assigned.
  • Good scientific assessment and writing skills.
  • Competency in medical/regulatory terminology.
  • High level of accuracy and attention to details.
  • Time and project management skills with ability to prioritize tasks.
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