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Regulatory Affairs Executive
1 week ago
Job Description:
- Responsible for writing clinical evaluation reports.
- Able to interpret, analyse and draw conclusions from the clinical data obtained from clinical trials, literature, etc.
- Responsible for preparing software documentation
- Responsible for preparing technical documentation for regulatory compliance (EU MDR, CDSCO)
- Responsible for preparing usability engineering documents
- Able to interpret and analyse ISO and IEC standards
- Assisting the design and development team with device verification and validation, as well as technical documentation drafting.
**Required Skills**:
- Experience with any medical device industry or service is MUST
- Experience in regulatory affairs and good technical documentation skills
- Regulatory compliance knowledge towards EU MDR, CDSCO is required
- Exposure to any of the post-market plans, Clinical Evaluation, risk management, labelling is a plus Knowledge on ISO 13485, ISO 14971, MEDDEV 2.7/1 Rev. 4, and IEC standards are preferred Knowledge of Medical Device Regulations for different global markets.
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Educational Background:
B.E Degree in Biomedical Engineering / Medical Electronics / Medical Instrumentation /equivalent domain
**Experience**:
1-2 years of experience in the relevant regulatory field in the medical device industry.
**Salary**: ₹200,000.00 - ₹350,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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