Job Information

- Date Opened 09/26/2026
- Job Type Full time
- Work Experience 1-3 years
- Industry Pharma/Biotech/Clinical Research
- City Pardi
- State/Province Gujarat
- Country India
- Zip/Postal Code 396191

About Us

MERIL

DELIVERING WORLD-CLASS HEALTHCARE SOLUTIONS Founded in 2006, Meril is an India-based, global medical device company that is dedicated to the innovation, design and development of novel, clinically relevant and state-of-the-art devices. Our fundamental aim is to champion the alleviation of human suffering and improve quality of life. To enable this, we are committed to R&D;, innovation in manufacturing medical technology, scientific communication, and contemporary distribution avenues.

Meril was born with the aim of improving the quality of human life through innovative and advanced healthcare solutions. As a medical device manufacturer, we exist to improve the inventiveness in healthcare so that people’s lives are enriched. We continually seek excellence in providing answers to some of medicine’s toughest questions.

Meril manufactures medical solutions in the form of vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endo-surgery and ENT products. It is our core commitment to ensure the delivery of advance healthcare solutions. Our inclination towards research and development is reflected in our diverse offerings.

We ensure that we adhere to the best quality of standards in manufacturing, scientific communication and distribution to deliver path-breaking healthcare products to the world.

We collaborate with physicians and global innovators to identify unmet clinical needs and develop revolutionary therapies. We encourage research and academic collaborations and remain available to interact on exciting opportunities.

Headquartered in India with a manpower of more than 4000, Meril currently conducts business in more than 100 countries. We have 100% subsidiaries in India, USA, Germany, Brazil, Russia, South Africa, Bangladesh and Turkey. We have set up operations in China and Japan too.

Role Purpose





Lead the end-to-end clinical evaluation and clinical evidence strategy for Class III implantable medical devices in compliance with Regulation (EU) 2017/745 (EU MDR). Own the preparation, review, approval and lifecycle maintenance of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), ensuring robust clinical evidence and alignment with post-market surveillance, risk management and product claims.

Key Responsibilities

- Lead preparation, review and periodic update of CEP and CER in accordance with EU MDR Article 61 and Annex XIV Part A, applying MEDDEV 2.7/1 Rev. 4 methodology as appropriate.
- Define clinical evidence strategy and assess clinical safety, performance, clinical benefit, benefit-risk acceptability, intended purpose, indications, claims and State of the Art (SOTA).
- Plan and oversee systematic literature searches, screening, critical appraisal, data extraction and analysis of clinical investigations and scientific literature.
- Establish objective safety and performance acceptance criteria/benchmarks, including acceptable rates or thresholds for adverse events, serious adverse events, device-related complications and undesirable side-effects, based on SOTA, relevant literature, clinical data and benefit-risk considerations.
- Apply appropriate statistical methods to evaluate adverse-event rates and determine/justify acceptance thresholds, including as applicable incidence/proportion estimates, confidence intervals, comparator or benchmark analysis, hypothesis testing, survival/time-to-event methods and trend analysis. Ensure statistical methods, assumptions and thresholds are scientifically justified and documented in the CEP/CER.




- Assess whether observed adverse-event and complication rates remain within predefined acceptance criteria and evaluate their impact on residual risk and benefit-risk acceptability.
- Determine whether clinical evidence is sufficient, identify evidence gaps, and define required PMCF and/or clinical investigation activities. Apply MDCG 2020-6 principles for sufficient clinical evidence for legacy devices, where applicable.
- Integrate and evaluate data from PMS, PMCF, PSUR, vigilance, complaints, registries, literature and clinical investigations throughout the device lifecycle.
- Prepare/review the Summary of Safety and Clinical Performance (SSCP) in accordance with EU MDR Article 32 and MDCG 2019-9 Rev.1, including appropriate presentation of undesirable side-effects/adverse events, their frequencies and relevant clinical outcomes.
- Ensure consistency across CER, SSCP, Risk Management File, PMS, PMCF, PSUR, GSPR, IFU/labeling, intended purpose and clinical claims.
- Lead responses to Notified Body clinical evaluation questions, findings and nonconformities and support clinical evidence discussions during conformity assessment.

Work cross-functionally with Regulatory Affairs, Medical Affairs, R&D;, Quality, Biostatistics, Risk Management, PMS/Vigilance, Clinical Operations and external consultants/CROs

Requirements

- Master’s degree or higher in Medicine, Pharmacy, Life Sciences, Biomedical Engineering, Clinical Research, Biostatistics or related discipline; PhD/PharmD preferred.
- 5–8 years of relevant medical-device clinical/regulatory experience, with substantial hands-on experience in Class III and/or implantable devices.
- Demonstrated experience authoring/reviewing EU MDR CERs, defining clinical safety/performance endpoints and acceptance criteria, interpreting statistical analyses, and addressing Notified Body clinical evaluation questions.
- Robust expertise in systematic literature review, SOTA, critical appraisal, clinical statistics, adverse-event analysis, benefit-risk evaluation, PMS/PMCF and scientific writing.

Benefits

Mobile Bill

📌 Clinical Evaluation (Killa-pardi)
🏢 Meril Life Sciences
📍 Killa-pardi