Regulatory Affairs and Quality Assurance Associate (Medical Device)

About the job

Experience/Knowledge/Technical Skills Required:


1. Around 2 to 5 years of experience in implementation in the QA domain preferably with some experience in working in the Medical Devices industry

2. Internal/Lead Auditor of Quality Management Systems

3. Knowledge and application skills of QC/Problem solving tools

4. Good computer skills
5. Knowledge of relevant regulatory/CE requirements for medical devices will be preferred 6. Analytical and structured working style, attention to details

7. Ability to work as part of a team

8. Good verbal and written communication skills


Roles & Responsibilities



1. Implementation and continuous improvement of the Medical Device Quality

2. Management Systems and associated CE requirements in order to meet customer

3. and regulatory requirements
4. Preparation, implementation, and Maintenance of Manual, policies, work instructions as per ISO 13485 5. Preparation, implementation, and Maintenance of Technical documentation (MDR) wrt applicable requirements

6. Review and formal approval of technical reports.

7. Facilitate internal/external audits and evaluate audit findings and implement

8. appropriate corrective actions

9. Investigate customer complaints and non-conformance issues

10. Analyse data to identify areas for improvement in the quality system

11. Identify training needs and organize training interventions to meet quality standards

12. Monitor risk management activities

13. Responsible for document management systems

14. Managing the Inventory & Batch Verifications
15. Management Representative: responsibilities shall be -

a. ensuring that processes needed for the quality management system are documented;

b. reporting to top management on the effectiveness of the quality management system and any need for improvement;

c. ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.