Quality Assurance – Design History File

Madhu Instruments

About us Madhu Instruments Pvt Ltd (MIPL) manufactures high quality medical devices specializing in ophthalmology. Our commitment towards quality is paramount. With a proven track record of cutting-edge innovation and a reputation for adhering to the international best practices, quality compliance and reliability, we offer a myriad of ophthalmic devices to ensure best care for patients and hassle-free procedures for the doctors. Objective Ensure the compliant compilation, documentation, and maintenance of Design History Files (DHF), Design Files, and Technical Documentation for medical devices. Adhere to ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR 2017/745, guiding cross-functional teams to meet regulatory timelines and audit readiness. Key Responsibilities 1. Develop and maintain DHF/Design Files and Technical Documentation per: o ISO 13485:2016 (Clause 7.3 – Design & Development) o FDA 21 CFR 820.30 (Design Controls) o EU MDR 2017/745 (Articles 10, 61, 83; Annexes II & III) 2. Liaise with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to gather and consolidate inputs. 3. Align documentation with EU MDR Annex III (PMS Technical Documentation) and track actions for CE marking and FDA 510(k) submissions. 4. Develop and monitor project timelines, integrating EU MDR milestones (e.g., PMS updates, CER revisions). 5. Provide regular (weekly/monthly) updates on progress, compliance gaps, and risks to the QA Manager, R&D Manager, and Managing Director. 6. Prepare DHF and Technical Documentation for Notified Body audits, FDA inspections, and internal audits. 7. Collaborate with Risk Management to ensure files reflect EU MDR Annex I (GSPR) and Annex III (PMS requirements). Qualifications Education: Bachelor’s degree in pharmacy (B. Pharma) or Biomedical Sciences or Diploma in Regulatory Affairs or M. Tech in Medical Devices Experience: 3+ years in QA/RA within the medical device industry Hands-on experience with DHF/Technical Documentation under FDA 21 CFR 820 and EU MDR 2017/745 Familiarity with Annex II/III requirements, clinical evaluation reports (CERs), PMS, and clinical evidence Skills: Strong understanding of EU MDR Articles 10, 61, 83 and GSPR checklist implementation Expertise in cross-functional project management and timeline tracking Proficient in English language Excellent computer knowledge Preferred Attributes Certification in Regulatory Affairs (RAC) or Quality Auditing (CQA). Experience with UDI requirements under EU MDR and FDA. Knowledge of the EUDAMED database and technical documentation submissions. Job Type: Permanent Pay: ₹30,000.00 - ₹40,000.00 per month Benefits: Health insurance Leave encashment Provident Fund Work Location: In person