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Are you passionate about regulatory affairs, quality assurance, and R&D in the medical device industry? Dentakris, a leading medical device manufacturing company, is hiring for a Regulatory Affairs & Quality Assurance (RA & QA) Executive in Meerut, Uttar Pradesh.
This is a perfect opportunity for candidates with 2–5 years of experience in regulatory submissions, ISO 13485 compliance, and QA in medical devices or pharmaceuticals.
Key Responsibilities
Regulatory Affairs
- Prepare and submit CDSCO MD-5 applications and manage authority communications.
- Compile, review, and maintain EU MDR CE Technical Files.
- Handle international product registrations for Dentakris devices.
- Monitor compliance with local and international regulatory requirements.
Quality Management System (QMS)
- Develop, implement, and maintain QMS documentation (ISO 13485).
- Draft and update SOPs, manuals, and regulatory process documents.
- Support internal & external audits and inspections.
Production Floor Quality Assurance
- Ensure QA compliance during manufacturing.
- Conduct in-process and final product quality checks.
- Investigate, document, and resolve non-conformities (CAPA).
Qualifications
- Education: B.Pharm / M.Pharm / M.Sc / Biomedical Engineering (or related).
- Experience: 2–5 years in Regulatory Affairs, QA, or Medical Device R&D.
- Strong knowledge of CDSCO, EU MDR, ISO 13485 standards.
- Excellent documentation and audit management skills.
Benefits
- Work with a leading medical device manufacturer.
- Exposure to global regulatory frameworks.
- Opportunities for career advancement in RA, QA, and R&D.
- Competitive salary package (INR 4–7 LPA).
How to Apply
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