Quality Assurance (Design File Compliance)

Company Overview

Madhu Instruments Pvt. Ltd.

Senior Executive Quality Assurance (Design File Compliance)

Department:

Reports To:

Collaborates With:

Location:

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.