Hiring for a Head QARA (Quality Asuurance and Regulatory affairs) for a leading medical device company..
Location- Gurgaon
Exp- 15-20 years
Job profile- Identify need for new regulatory requirements / policies, processes and SOPs and approve them.
Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
·Establishes monitoring policies and procedures to ensure compliance with existing regulations and upcoming projects like Indian MDR, EUMDR, USFDA, ENVISA, TGA etc.
·To ensure the device manufacturing process are in the compliance with the QMS
To maintain all kind of QA/RA documentations to ensure smooth compliance
US FDA/CE/Important Regulatory/Product Registrations
· Responsible for the timely completion of regulatory projects and submission of documentation to regulatory agencies
· Analyse and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
Interested candidates can write to me at [email protected]
