Founded in 1991, Mindray is one of the leading global providers of medical devices and solutions. Firmly committed to our mission of “advance medical technologies to make healthcare more accessible”, we are dedicated to innovation in the fields of Patient Monitoring & Life Support, In-Vitro Diagnostics, and Medical Imaging System.
Headquartered in Shenzhen, China, Mindray possesses a sound global R&D, marketing and service network with subsidiaries and branch offices in 32 countries in North and Latin America, Europe, Africa and Asia-Pacific, as well as 31 branch offices in China.
Inspired by the needs of our customers, we adopt advanced technologies and transform them into accessible innovation, bringing healthcare within reach. While improving the quality of care, we help reducing its cost, making it more accessible to a larger part of humanity. Today, Mindray’s products and services can be found in healthcare facilities in over 190 countries and regions. In China, Mindray’s products and solutions can be found in nearly 110,000 medical institutions and 99% of Class A tertiary hospitals.
Designation- Sr. Manager- Regulatory Affairs
No. of Position- 1
Location- Gurgaon
Experience- 5 years in a Medical Devices / Consumables company in product Regulatory department
Educational Qualification-
Job Responsibilities:
- Write, review, and submit registration technical file, including but not limited to DMF.
- Responsible for Product sanitary registration, renewal, and modification, i.e. MD-15, ISI, etc. as per the law of land with various product regulatory authorities, i.e. CDSCO, BIS, EPR, TRAI, etc. Maintain regular progress tracking report, make alert of the delays in advance.
- Keep smooth communication and work closely with different evaluators about queries and registration to get the license ASAP.
- Responsible to keep data records of registered products of MRIN and distributors, and archive the original documents or paper.
- Responsible for proactively initiate the renewal process well in advance before the existing license expiry to ensure the continuity of the business.
- In case of CLA or State Licensing Authority’s inspection, find out the procedures and make preparation in advance.
- Clarify the local GMP and other quality system requirements.
- Keeping track of all the departmental notification, assist the Manager to represent the company in different regulatory forum, and pass the memorandum to relevant parties in time.
- Investigate and clarify regulatory requirements and guidelines, and output work guidelines, flowchart or training if necessary.
- Responsible for the co-ordination to obtain the related documents, samples from the various department of HQ that’s required for the renewal / registration
- Work closely with different Govt. appointed Labs to monitor the progress of the test reports required for the renewal / registration
- Maintain regular progress tracking report and make alert of the delays in advance.
- Responsible to work closely with the company appointed consultants, identify the rationality of request, avoid waste of resources and time, and obtain the progress so that the license is issued ASAP
- Responsible to keep the required licenses as a repository
- Raise the flag on the requirement of the registration for NPI to the product team
