Sr. Regulatory Affairs Officer Job in Surgimedik Healthcare at Kandivali West, Mumbai

Sr. Regulatory Affairs Officer

Surgimedik Healthcare

2 Years

Not disclosed

Expired

Posted: 21 Jun 18

Co-ordination and preparation of necessary documentation and reports for Medical Device technical files, and operation of the file review and maintenance system.
Compliance activities for the Medical Device products. Indian and International.
Regulatory participation in Medical Device Project work and Notified Body audits when necessary.
To support QA, helping to ensure that our ISO 13485 accreditation is maintained.
To maintain a knowledge and familiarity with current regulatory requirements for all aspects of the job.
To support the Regulatory Team Leader in the reporting and analysis of the departmental performance.
To attend as required appropriate industry regulatory meetings, also self-learn

Experience Required:

Degree in Life Sciences or equivalent.
Prior experience within a regulatory function covering Medical Devices, minimum 2 years.
Working knowledge ISO 13485 regulations.