
Executive Regulatory Affairs
5 days ago
**Primary Responsibilities**:
- **Regulatory Compliance**: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 ISO 20417, ISO 15223, ISO 10993-1 and other global standards. GSPR, Technical Documentation, Regulatory Gap Assessment.
- Standard Operating Procedure (SOP)
- **Labeling and Packaging**: Ensure compliance with labeling and packaging regulations, including content, design, and format requirements.
- Prepare technical documentation dossiers for regulatory submissions, including design controls, risk management plans, and performance testing data.
- **Product Development**: Collaborate with cross-functional teams to develop new products, ensuring regulatory compliance throughout the product lifecycle.
- **Audits and Inspections**: Coordinate internal audits and prepare for FDA inspections by ensuring compliance with regulations and maintaining accurate records.
- **Compliance Monitoring**: Monitor compliance with company policies, procedures, and regulatory requirements, identifying areas for improvement and implementing corrective actions as needed.
**Work Experience**
**Desired Skills and Qualifications**:
- Bachelor’s / Diploma / master’s degree in a related field, related life science.
- 3-6 years of experience in medical device industry
- Minimum 4years of experience in medical device regulatory affairs, preferably with experience in the active medical device (Entire life cycle).
Pay: ₹25,000.00 - ₹30,000.00 per month
**Benefits**:
- Food provided
- Provident Fund
Schedule:
- Day shift
**Experience**:
- total work: 1 year (preferred)
Work Location: In person
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