|| Senior Regulatory Affairs Associate
Plot No. 169-170, Phase-IV,
Sector-57, Kundli Industrial Area,
- 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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