- Key Responsibilities
- 1. Quality Control Manager: Oversee sampling, inspection, and lot release testing for raw materials, biochemical reagents, electrochemical biosensors/test strips, and finished electronic diagnostic instruments.
- Analytical & Functional Validation: Define and execute test protocols for lot-to-lot repeatability, precision, linearity, analytical sensitivity, shelf-life stability (real-time and accelerated), and interference testing.
- Laboratory Integrity & Equipment: Maintain calibration, IQ/OQ/PQ, and qualification of analytical equipment (potentiostats, reagent dispensing systems, environmental chambers, optical/inspection tools) under Positive Laboratory Practice (GLP).
- Investigation & CAPA: Lead root-cause investigations for Out of Specification (OOS), Out of Trend (OOT), non-conformances (NCR), and corrective/preventive actions (CAPA) across fabrication and assembly lines.
- 2. Regulatory Affairs (RA) & CE Marking (IVDR)CE Marking (EU IVDR 2017/746):
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- Establish, compile, and maintain the IVDR Technical Documentation (Annex II & III) for handheld readers, firmware/software (SaMD/SiMD), and biosensor test strips.
- Oversee the Performance Evaluation Process (PEP), including the Performance Evaluation Plan, Scientific Validity Report (SVR), Analytical Performance Report (APR), Clinical Performance Report (CPR), and Post-Market Performance Follow-up (PMPF) Plan/Report.
- Serve as the primary technical liaison with EU Notified Bodies and the European Authorized Representative (EC REP); lead audit readiness, technical dossier reviews, and resolution of Notified Body queries.




- Coordinate with authorized labs and clinical partners to ensure compliance with European Common Specifications (CS) and harmonized standards.
- Domestic Regulatory Governance (CDSCO):
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- Author, submit, and manage manufacturing licenses, test licenses, and import/export filings on the SUGAM / MD-Online portal under the Indian Medical Device Rules (MDR) 2017 (Forms MD-7, MD-9, MD-14, MD-15, etc.).
- Coordinate statutory performance evaluations with designated central testing laboratories (e.g., NIB, ICMR institutions).
- Quality Management System (QMS) & Audits:
- Direct and maintain compliance with ISO 13485:2016 and IVDR QMS requirements.
- Lead internal audit programs, host external Notified Body/CDSCO audits, and oversee Management Reviews.
- Post-Market Surveillance & Vigilance:
- Build and maintain the Post-Market Surveillance (PMS) system, generating periodic safety update reports (PSUR / PMS reports), vigilance filings, and managing Field Safety Corrective Actions (FSCA) if required.
- 3. Cross-Functional Leadership & TransferCollaborate closely with R&D;, biosensing chemistry, instrumentation, software, and manufacturing teams to ensure Design Controls (ISO 13485 / Design Dossiers) and risk management (ISO 14971) align with CE and CDSCO requirements during design transfer.




- Supervise and mentor QC analysts and lab technicians, establishing robust standard operating procedures (SOPs).

- Qualifications & ExperienceEducation:
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- Master’s or Bachelor’s degree in Biomedical Engineering, Biotechnology, Biochemistry, Analytical Chemistry, Pharmacy, or a related discipline.
- Experience:
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- 5 to 10 years of progressive experience in Quality Control and Regulatory Affairs within the In-Vitro Diagnostics (IVD) or medical device industry.
- Proven track record with CE marking: Hands-on experience authoring or updating technical documentation under EU IVDR 2017/746 (or transitioning files from IVDD to IVDR) and direct interaction with European Notified Bodies (e.g., TÜV, BSI, DNV).
- Direct experience with CDSCO MDR 2017 regulatory submissions for Class B/Class C IVD devices.
- Direct experience managing ISO 13485:2016 certified quality systems.
- Technical Competencies & StandardsRegulatory Frameworks: EU IVDR 2017/746, Indian MDR 2017, ISO 13485:2016, ISO 14971:2019 (Risk Management), IEC 62304 (Medical Device Software Lifecycle), IEC 61010-2-101 (Safety requirements for IVD equipment), ISO 15197 (In vitro blood-glucose monitoring systems).
- Technical Writing: Comprehensive experience with IVDR Annex II/III dossiers, Device Master Records (DMR), Performance Evaluation Reports (PER), labeling, and Instructions for Use (IFU).
- Methodologies: Electrochemical biosensor testing (amperometry, cyclic voltammetry), lot release statistics, Gage R&R;, and Statistical Process Control (SPC).

📌 Quality Control Manager (Bengaluru)
🏢 Pathshodh Healthcare Private
📍 Bengaluru