HR at NeuroEquilibrium Diagnostic Systems Pvt Ltd
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NeuroEquilibrium - Manager - Regulatory Affairs (6-7 yrs)
About Neuro Equilibrium: (CE & ISO 13485 Certified Organization):
NeuroEquilibrium is a Medical Technology ( MedTech) company pioneer in the field of vertigo and balance disorders aiming to provide advanced and economical diagnosis and treatment to people suffering from these conditions. We are making groundbreaking innovations in this field by developing indigenous vertigo diagnostic systems which operate on cutting-edge cloud technology. We have CE certifications & 6 patents on our product. We have a very strong hardware and software development team which is developing world class products impacting lives of millions of people.
NeuroEquilibrium has over 150 clinics in India and has installations in top hospitals including AIIMS Delhi etc. The company is well funded with investments from Kotak Ventures, Unicorn India Ventures, RVCF etc
To know more about Neuro Equilibrium, please visit: https://www.neuroequilibrium.in
Neuro Equilibrium is looking for Regulatory Affairs Managers to support and manager regulatory compliance requirements and audits and to make this a continuous process wherever applicable related to regulatory requirements, business objective's, client need's or documentation purposes.
What is the role like:
For this role, we are looking for the people who has exposure in the global compliance requirements and documentation into healthcare and medical devices segments. Additional responsibilities, this role will have as below:
- Ensure regulatory compliance with relevant global medical device regulations specifically for FDA and CE.
- Will be responsible for obtaining FDA for the organization's devices.
- Will be responsible for CDSCO compliance's.
- Will be working on regulatory requirements, electronic submissions as per industry trends and standards.
- Will be preparing and compiling the dossier based on the needs for the regulatory processes.
- This role will be responsible for periodic audits as and when required as per the processes.
Skills do we look for:
- Strong interpersonal skills.
- An excellent communicator and goal oriented.
- A good researcher about the latest trends in the regulatory and compliances fields.
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