
Regulatory Affairs Executive
4 days ago
We are in the process of hiring Regulatory Affairs
**Job Title**: Regulatory Affairs Executive
**Key Responsibilities**:
**Qualifications**:
Bachelor Degree in a related field such as Biomedical engineering, Mechanical engineering with minimum of 2 years’ progressive Regulatory affairs experience in medical device & quality background.
**Requirements**:
- Ensure that a company's products comply with the regulations of the regions
- Keep up to date with national and international legislation, guidelines and customer practices
- Collect, collate and evaluate scientific data from a range of sources
- Monitor and set timelines for variations and renewal approvals
- Work with specialist computer software and resources
- Write clear, accessible product labels and patient information leaflets
- Plan and develop product trials and interpret trial data
- Advise scientists and manufacturers on regulatory requirements
- Provide strategic advice to senior management throughout the development of a new product
- Project manage teams of colleagues involved with the development of new products
- undertake and manage regulatory inspections
- Review company practices and provide advice on changes to systems
- Liaise with, and make presentations to, regulatory authorities
- Negotiate with regulatory authorities for marketing authorization
- Take part in the development of marketing concepts and approve packaging and advertising before a product's release.
- Knowledge about ISO 9001 ,ISO 13485
- Knowledge about MDR(Medical device regulations)
**Job Types**: Full-time, Regular / Permanent
Benefits**:Health insurance ** Provident Fund
Schedule: Day shift
Total work Experience: 2 to 3 Years
Language: English
Work Remotely: No
**Salary**: INR 15000 - INR 18000 per month
Pay: ₹15,000.00 - ₹18,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Morning shift
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