Regulatory Affairs Executive
Aegis Lifesciences
Full time- 2+ years
- Not Disclosed
- Ahmedabad, India
- Post Date: Mar 18, 2024
- End Date: Jun 18, 2024
- 2+ years
- Not Disclosed
- Ahmedabad, India
- Post Date:Mar 18, 2024
- End Date: Jun 18, 2024
Skills:
- Regulatory Affairs
- Management
- Communication
Job Description:
Responsibilities
The RA Executive shall report to the Head of QA/RA, and is responsible to assist him in the following areas:
- Leading new products registration and license renewal in various countries
- Compliance for international as well as local regulations for various class of medical devices
- To Lead QA/RA team and ensure quality SOPs within the company
- Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment
- Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes
- Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects
- Keep abreast of International legislation and guidelines of current product line in India
- Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements
- Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements
- Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production, RA & QA team to provide advice on process and labeling changes
- Review of SOPs, BPRs, specifications and change control to ensure compliance
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks
- Drives resolution of issues, communicates issues, impact and outcomes to the management team
- Responsible for ensuring compliance to the submission standards, procedures and policies in India
- Support Commercial Department in business development such as product evaluation and pre-launch activities
- Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc
Qualification & Experience
- More than 2 years of experience in technical documentation, regulatory affairs and quality assurance in the medical device industry
- Bachelors degree in relevant field. Master's is desirable
- Ethical behavior and high level of integrity
-
Salary
Not Disclosed
-
Role
Executive or Officer
-
Area of Practice
- Regulatory Affairs
-
Experience
2+ years
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