Madhu Instruments Pvt Ltd
Website:
madhuinstruments.com
Job details:
Company Overview
Madhu Instruments Pvt. Ltd. is a leader in precision medical device manufacturing, committed to innovation, quality, and global regulatory compliance. With state-of-the-art facilities and a customer-centric approach, we develop and deliver cutting-edge diagnostic and therapeutic products that improve patient outcomes worldwide.
Senior Executive – Quality Assurance (Design File Compliance)
Department: Quality Assurance
Reports To: QA Manager
Collaborates With: R&D | Regulatory Affairs | Manufacturing | Senior Leadership
Location: Delhi
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
Design File Compliance
- Develop and maintain DHF/Design Files and Technical Documentation per:
- ISO 13485:2016 (Clause 7.3 – Design & Development)
- FDA 21 CFR 820.30 (Design Controls)
- EU MDR 2017/745 (Articles 10, 61, 83; Annexes II & III)
- Include device description, intended purpose, specifications, GSPR checklist, risk management (ISO 14971), verification/validation protocols, clinical evaluation reports, and PMS plans.
- Ensure full traceability between design inputs, outputs, risk controls, and regulatory requirements.
Cross-Functional Coordination
- Liaise with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to gather and consolidate inputs.
- Align documentation with EU MDR Annex III (PMS Technical Documentation) and track actions for CE marking and FDA 510(k) submissions.
Timeline Management & Reporting
- Develop and monitor project timelines, integrating EU MDR milestones (e.g., PMS updates, CER revisions).
- Provide regular (weekly/monthly) updates on progress, compliance gaps, and risks to the QA Manager, R&D Manager, and Managing Director.
Regulatory Audit & Inspection Readiness
- Prepare DHF and Technical Documentation for Notified Body audits, FDA inspections, and internal audits.
- Address findings related to EU MDR compliance (clinical evaluation, PMS data, UDI traceability) and FDA observations.
Risk Management & Post-Market Surveillance
- Collaborate with Risk Management to ensure files reflect EU MDR Annex I (GSPR) and Annex III (PMS requirements).
- Support updates to risk management files and PMS reports post-market launch.
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
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.
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