Raqa Specialist
Year India, India
Job Description
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Sebia is a dynamic company in full expansion, we have many projects that lead us to open new subsidiaries every year !
Our mission is to provide powerful tools that translate what is happening in a patients\xe2\x80\x99 body into a readable and interpretable language.
We call it our new language of life.
- Build and maintain effective relationships with regulatory bodies, including but not limited to FDA, CDSCO, ICMR, and NIB.
- Collaborate with internal teams to ensure regulatory compliance throughout the product life cycle.
- Prepare and submit regulatory documents, ensuring accuracy and completeness.
- Manage regulatory submissions and responses to inquiries from regulatory agencies.
- Identify and assess regulatory risks associated with IVD products. Develop and implement strategies to mitigate regulatory risks.
Conduct training sessions for internal teams to enhance regulatory awareness. Keep the organization informed about changes in regulations and their implications. - Qualified documents a series of Quality Management System activities required for quality management
- Preparation and record management of related documents to meet the Quality Management System (QMS) requirements under the Import In Vitro Diagnostic Medical Devices Rules 2017.
- Compliance with Sebia and domestic regulations as per other relevant laws and operations to ensure the maintenance of the quality management system.
Be an actor of your career and its evolution.
If you want to work for a company where missions make sense and foster your personal development, join the Sebia adventure!
For more information, please visit our career page: https://www.sebia.com/sebia/join-us/
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Job Detail
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Job IdJD3290709
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationIndia, India
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EducationNot mentioned
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ExperienceYear