Job Title: QA/RA Manager(orthopedic)

Location:-Okhla ,Delhi

Exp:-7yrs to 10 yrs

Salary:-50k to 80k

Contact via WhatsApp:-(phone hidden)

Key Responsibilities

Regulatory Affairs (RA):-

Ensure compliance with applicable global regulations: Indian MDR, ISO 13485, EU MDR(2017/745), USFDA 21 CFR 820, and MDSAP.

Prepare and maintain regulatory submissions (Technical Files, 510(k), STED, etc.) for CE Marking, USFDA clearance, and Indian CDSCO licensing.

Serve as the primary contact for regulatory authorities and Notified Bodies.

Monitor and interpret changes in regulations; ensure timely implementation within QMS and product lifecycle.

Manage product registrations, renewals, and labeling compliance in domestic and international markets.

Support clinical evaluation reports (CER), risk management (ISO 14971), and post-market surveillance.

Quality Assurance (QA):-

Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with ISO 13485.

Lead internal audits, external audits, and regulatory inspections (CDSCO, NB, USFDA).

Drive CAPA and non-conformance (NC) management: lead root cause analysis, define corrective/preventive actions,



and monitor effectiveness.

Oversee Change Control, design reviews, and process validations.

Manage Document Control for DHFs, DMRs, SOPs, risk files, batch records, and validation protocols.

Approve and release product batches post review of sterilization, biocompatibility, andinspection data.

Supervise vendor quality audits, material reviews, and supplier scorecards.

Ensure effective training programs on GMP, QMS, and regulatory requirements across all departments.

Product & Process Oversight:-

Lead design assurance activities, including risk analysis (ISO 14971), design verification/validation, and usability studies.

Oversee sterilization validation (ISO 11135 for EO) and ongoing routine controls.

Supervise cleanroom environmental monitoring and contamination control measures.

Coordinate with cross-functional teams (R&D;, Manufacturing, QC, RA) to ensure compliance throughout the product lifecycle.

Immediate joiners required

Regards

Neha

(phone hidden)

Pay: ₹50,000.00 - ₹80,000.00 per month

Work Location: In person

📌 Quality assurance and regulatory affair officer-orthopedic (Okhla)
🏢 Mr solution
📍 Okhla