Regulatory Affairs Executive

1 day ago

Guindy Chennai Tamil Nadu, India Tekna Manufacturing Full time

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 5 to 7 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: ₹40,000.00 - ₹50,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Morning shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

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