IF MedTech Pvt Ltd | Officer- Regulatory Affairs IVD

2 weeks ago


india IF MedTech Pvt Ltd Full time

Company and Job Description

IF MedTech Pvt Ltd in Navi Mumbai is dedicated to revolutionizing healthcare through cutting-edge medical device design, development, and pilot manufacturing. The global team collaborates across medical, engineering, business, and research domains to bring innovative solutions that enhance healthcare and improve lives.


This is a full-time on-site role for an Officer-IVD Regulatory at IF MedTech Pvt Ltd in Navi Mumbai. The Officer will be responsible for regulatory documentation, compliance, requirements, affairs, and submissions on a day-to-day basis.


Role and responsibility as Officer-IVD Regulatory


Analytical Performance Evaluation

Design and execute studies to assess analytical performance parameters, including:

Analytical Sensitivity and Analytical Specificity, Trueness (bias), Precision (repeatability and reproducibility), and Accuracy, Limits of Detection (LOD) and Limits of Quantitation (LOQ), Measuring Range, Linearity, and Cut-off Values.

Interpret and document findings to ensure compliance with ISO 20916, IVDR (EU 2017/746), and applicable international standards.


Clinical Performance Evaluation

Design and execute studies to evaluate clinical performance parameters, including:

Diagnostic Sensitivity, Diagnostic Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV), Likelihood Ratios (Positive and Negative). Determination of expected values in normal and affected populations.

Develop and implement strategies for gathering clinical data, including clinical trial design and literature reviews.


Regulatory Compliance and Documentation

Prepare and maintain Performance Evaluation Reports (PERs), Technical Documentation, and Post-Market Performance Follow-Up (PMPF) plans in compliance with global regulatory standards.

Collaborate with Regulatory Affairs to ensure performance data supports regulatory submissions


Risk Management

Integrate performance evaluation findings into the Risk Management File (ISO 14971) to ensure patient safety and device efficacy.

Perform risk-benefit analyses based on analytical and clinical performance data.


Post-Market Surveillance

Support Post-Market Performance Follow-Up (PMPF) activities to monitor and ensure the ongoing accuracy, sensitivity, and specificity of IVD products.

Address performance-related issues identified during post-market surveillance or regulatory audits.


Key Qualifications:

Bachelor’s or Master’s degree in Biotechnology, Biochemistry, Molecular Biology, or a related field.

Minimum 2–5 years of experience in IVD performance evaluation, focusing on analytical and clinical performance.

Proven experience with global IVD regulations, including IVDR, FDA 21 CFR 809, and ISO 20916.

Strong knowledge of analytical and clinical performance evaluation methodologies for IVD devices.

Expertise in statistical analysis of performance data and use of software tools for data interpretation.

Familiarity with relevant quality standards, including ISO 13485, ISO 14971 and CLSI.


Skills and Competencies

Exceptional analytical and critical thinking skills.

Proficiency in technical writing and preparation of regulatory documentation.

Strong project management and organizational skills.

Effective communication skills for cross-functional collaboration and regulatory discussions.



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