Regulatory Affairs
6 days ago
Major Duties & Responsibilities:
- Monitors regulatory affairs and the effect changes will have on company operations
- Responsible for preparing and submitting regulatory documentation, including reviewing technical data and accuracy of filling.
- Technical understanding of EU ISO13485:2016, 21CFR 820
- EUMDR2017/745, PPE 2016/425, USFDA, MDR 2017 (As per CDSCO.
- Responsible for assuring that all developed products/processes should represent the maximum quality & reliability attainable by establishing effective quality control inspections & corrective procedures.
- Assessing technical documents as required standards (US& EU)
- Provide quality and regulatory affairs input for product development.
- Handle all TQM & RA responsibilities through product development, design change, and post-market surveillance process.
- Dossier preparation & submission and related activities to it & Post Submission support.
- SOP preparation as per country guidelines for Dossier submission to be aligned with the requirement.
- Keeping Track of Regulatory Requirements for changes and implementing them in the system.
- Responsible for Process improvement for the Product approval process.
- Maintain and continuously improve Quality System processes required by international and national regulatory authorities and standards.
- Maintains current knowledge of regulations applicable to the company.
**Required Skill Set**:
- Extensive knowledge of EU & US government regulations.
- Knowledge of pharmacopeia (EU, USP, JAPAN, INDIA)
- Excellent communication skills
- Problem-solving skills
- Good attention to detail
- Technical skills: EU ISO 13485:2016, USFDA, EUMDR, 21CFR etc**.**
**Interested Can call at
+91-XXXXXXXXXX
**Salary**: Up to ₹600,000.00 per year
**Benefits**:
- Cell phone reimbursement
- Commuter assistance
Schedule:
- Morning shift
Supplemental Pay:
- Commission pay
Ability to commute/relocate:
- Vasai, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 1 year (preferred)
**Speak with the employer**
+91
+91-XXXXXXXXXX
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