Regulatory Affairs Associate
1 week ago
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 Skill Sets**:
- 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 on Medical Device Regulations for different global markets.
**Salary**: ₹15,000.00 - ₹18,000.00 per month
**Benefits**:
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Navi Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 2 years (preferred)
**Speak with the employer**
+91 9004517483
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