Job Title: R&D Microbiologist Experience Level: 0-1 year. Location: Siruseri, Chennai About Us MicroGo is committed to the One Health approach, integrating human, animal, and environmental health. Their work culture is characterized by openness, interactivity, and a non-hierarchical structure. Role Summary They are seeking a skilled and motivated microbiologist to join their team. The chosen person will take care of the microbiology lab according to USP-1117 standards, perform tests on microbes, and help with farming projects that focus on minimizing losses after harvest. This role involves collaborating with farmers, agricultural experts, and government entities to pilot and field-test new storage technologies. Key Responsibilities - Maintain and operate the microbiological laboratory in compliance with USP-1117 standards for research and quality control. -Conduct microbial examination, culturing, identification, media preparation, and aut...
HiMedia Requires Manager Regulatory
Affairs ( Microbiology)
Details are provided below
1. Company- HiMedia Laboratories Pvt Ltd
2. Post - Manager - Regulatory Affairs ( Microbiology)
3. Qualification Required- Ph. D./ Master's Degree in Microbiology/ Biotechnology + Diploma or equivalent in Regulatory or related field required.
4. Job Responsibilities
a. To ensure that company's products comply with medical devices regulations of different regions where they intend to be marketed.
b. Well versed with Medical Devices Rules followed in India and Overseas.
c. To involved in registration of Medical Devicea in CDSCO and other International regulatory agencies
d. Calibration with cross functional teams ( for eg R and D , Manufacturing, Quality etc ) for inputs in dossier preparation.
e. Dossier preparation such as device master file for CDSCO. Technical files preparation for Europe submissions.
f. Preparation of post market surveillance reports , incident reports to Regulatory
g. Additional knowledge of ANVISA, TGA , USFDA , SFDA REACH and MEDSAP can be an added advantage.
h.Should be well versed with online application processes of CDSCO and NSWS for obtaining manufacturing license. Test license , import license, Free sale certification, Non Conviction certificate , post approval process , license renewal etc.
i. Capacity to manage data for accurate presentation of documents to authorities as and when required.
j. Participate in CDSCO and other Regulatory audits and FDA inspection while adding to the rules and regulations set by government.
k. Respond to queries from Regulatory Authorities
l. Train Personnel on Regulatory requirements.
5. If you are interested and meeting above experience, kindly share your CV to vsalvi@himedialabs.com
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