Website Dentakris
Company Overview
Dentakris, a trusted name in the medical device manufacturing industry, is committed to innovation, safety, and quality. With a strong presence in domestic and international markets, Dentakris ensures its devices meet the highest regulatory and quality standards.
Location
Meerut, Uttar Pradesh
Role Overview
We are seeking a skilled and detail-oriented Regulatory Affairs & Quality Assurance (RA & QA) Executive to support our regulatory submissions, maintain compliance with ISO 13485, and ensure quality across R&D and manufacturing operations. This role is ideal for professionals with 2–5 years of experience in regulatory affairs, quality assurance, or medical device R&D.
Key Responsibilities
Regulatory Affairs
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Prepare and submit CDSCO MD-5 applications and manage communications with authorities.
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Compile, review, and maintain EU MDR CE Technical Files.
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Manage international product registrations for Dentakris devices.
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Ensure compliance with local and global regulatory requirements.
Quality Management System (QMS)
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Develop, implement, and maintain QMS documentation in line with ISO 13485.
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Draft and update SOPs, quality manuals, and regulatory process documents.
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Support internal and external audits and inspections.
Production Floor Quality Assurance
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Monitor and ensure QA compliance during the manufacturing process.
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Conduct in-process and final product quality checks.
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Investigate, document, and resolve non-conformities (CAPA).
Qualifications
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Education: B.Pharm / M.Pharm / M.Sc / Biomedical Engineering (or related discipline).
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Experience: 2–5 years in Regulatory Affairs, QA, or Medical Device R&D.
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Strong knowledge of CDSCO, EU MDR, and ISO 13485 standards.
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Excellent documentation, audit handling, and compliance management skills.
Benefits
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Opportunity to work with a leading medical device manufacturer.
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Exposure to global regulatory frameworks and compliance systems.
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Professional growth in RA, QA, and R&D domains.
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Competitive salary package: INR 4–7 LPA.
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To apply for this job please visit docs.google.com.