SPG Medisafe Pvt. Ltd.
Website:
spgmedisafe.com
Job details:
We're Hiring | Regulatory Affairs & QA/QC Manager
📍 Location: Mumbai, Maharashtra
🕒 Employment Type: Full-Time
🏢 Company: SPG Medisafe Pvt. Ltd.
SPG Medisafe Pvt. Ltd, a leading manufacturer of urology and medical devices, is looking for an experienced Regulatory Affairs & QA/QC Manager to lead our Quality Management System (QMS), regulatory compliance, and quality assurance functions.
Key Responsibilities:
✅ Manage ISO 13485 & ISO 14971 compliance
✅ Handle CDSCO, State FDA & CE regulatory submissions
✅ Lead QA/QC operations, CAPA & internal/external audits
✅ Oversee sterilization validation (ETO/Gamma/Steam) & risk management
✅ Support R&D, manufacturing, supplier audits & product lifecycle compliance
Candidate Profile :
1-Bachelor's/Master's in Biomedical Engineering, Pharmacy (M.Pharm) or 2-Microbiology
Minimum 7–10 years of experience in Medical Device Regulatory Affairs & QA/QC
Experience with Class B & Class C Medical Devices preferred.
3-Strong knowledge of MDR 2017, ISO 13485, ISO 14971 & validation activities.
Mumbai-based candidates will be preferred
✔ Opportunity to work with a fast-growing medical device manufacturer
✔ Exposure to national & international regulatory projects in
✔ Competitive salary as per industry in standards
✔ Career growth in an innovation-driven organization
📩 Apply Now
Send your resume to
info@spgmedisafe.com
📞 Contact: +91 79057 50203 | +91 70455 96409
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