Clinical Evaluation

Meril GmbH; India; Presencial; INR 1.800.000 - 2.400.000; Jornada completa

Descripción de la vacante

MERIL in India seeks a seasoned professional to lead end-to-end clinical evaluation and clinical evidence strategy for Class III implantable medical devices, ensuring compliance with EU MDR. You will own CEP and CER documents, review lifecycle maintenance, and align with post-market surveillance, risk management and product claims.

Cross-functional collaboration with Regulatory Affairs, Medical Affairs, and R&D is essential.

Formación

• Master’s or higher in Life Sciences or related field with clinical/regulatory focus.
• Experience drafting EU MDR CERs and CEPs with robust clinical endpoints.
• Strong expertise in systematic literature reviews, SOTA, statistics and AES analysis.

Responsabilidades

• Lead preparation, review and periodic update of CEP and CER per EU MDR Article 61 and Annex XIV Part A; apply MEDDEV 2.7/1 Rev. 4 where appropriate.
• Define clinical evidence strategy and assess clinical safety, performance, clinical benefit, and risk acceptability.
• Plan and oversee systematic literature searches, screening, critical appraisal, data extraction and analysis of clinical investigations.
• Establish objective safety and performance acceptance criteria, including adverse-event thresholds.
• Apply statistical methods to evaluate adverse-event rates and justify thresholds; document in CEP/CER.
• Assess whether observed adverse events keep within acceptance criteria and impact residual risk/benefit.
• Determine evidence sufficiency and define PMCF or clinical investigation needs; apply MDCG 2020-6 as needed.
• Integrate data from PMS, PMCF, PSUR, vigilance, registries and literature across the lifecycle.
• Prepare/review the SSCP in accordance with EU MDR Article 32 and MDCG 2019-9 Rev.1.
• Ensure consistency across CER, SSCP, Risk Management File, PMS/PMCF, PSUR, and labeling.
• Lead responses to Notified Body evaluation questions and findings.
• Collaborate with Regulatory Affairs, Medical Affairs, R&D, Quality, Biostatistics, Risk Management and CROs.

Conocimientos

Clinical evaluation

CER drafting

EU MDR

MEDDEV 2.7/1

Statistical analysis

PMS/PMCF

Cross-functional leadership

Notified Body liaison

Clinical writing

Regulatory affairs

Educación

Master’s degree in Life Sciences

PhD/PharmD preferred

Descripción del empleo

• Industry Pharma/Biotech/Clinical Research
• City Pardi
• Country India

About Us

MERIL

DELIVERINGWORLD-CLASS HEALTHCARE SOLUTIONS

Founded in 2006, Meril is an India-based, global medical devicecompany that is dedicated to the innovation, design and developmentof novel, clinically relevant and state-of-the-art devices. Ourfundamental aim is to champion the alleviation of human sufferingand improve quality of life. To enable this, we are committed toR&D, innovation in manufacturing medical technology, scientificcommunication, and contemporary distribution avenues.

Meril was born with the aim of improving the quality of humanlife through innovative and advanced healthcare solutions. As amedical device manufacturer, we exist to improve the inventivenessin healthcare so that people’s lives are enriched. We continuallyseek excellence in providing answers to some of medicine’s toughest questions.

Meril manufactures medical solutions in the form of vascularintervention devices, orthopaedic supplements, in‑vitro diagnostics,endo‑surgery and ENT products. It is our core commitment to ensurethe delivery of advance healthcare solutions. Our inclinationtowards research and development is reflected in our diverseofferings. We ensure that we adhere to the best quality of standardsin manufacturing, scientific communication and distribution todeliver path‑breaking healthcare products to the world.

We collaborate with physicians and global innovators to identifyunmet clinical needs and develop revolutionary therapies. Weencourage research and academic collaborations and remain availableto interact on exciting opportunities.

Headquartered in India with a manpower of more than 4000, Merilcurrently 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.

Job Description

Role Purpose

Lead the end-to-end clinicalevaluation and clinical evidence strategy for Class III implantable medicaldevices in compliance with Regulation (EU) 2017/745 (EU MDR). Own thepreparation, review, approval and lifecycle maintenance of Clinical EvaluationPlans (CEP) and Clinical Evaluation Reports (CER), ensuring robust clinicalevidence and alignment with post-market surveillance, risk management andproduct 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, clinicalbenefit, benefit-risk acceptability, intended purpose, indications, claims andState of the Art (SOTA).
• Plan and oversee systematic literature searches, screening, critical appraisal, dataextraction and analysis of clinical investigations and scientific literature.
• Establish objectivesafety and performance acceptance criteria/benchmarks, including acceptablerates or thresholds for adverse events, serious adverse events, device-relatedcomplications and undesirable side-effects, based on SOTA, relevant literature,clinical data and benefit-risk considerations.
• Apply appropriate statistical methods to evaluate adverse-event rates anddetermine/justify acceptance thresholds, including as applicableincidence/proportion estimates, confidence intervals, comparator or benchmarkanalysis, hypothesis testing, survival/time-to-event methods and trendanalysis. Ensure statistical methods, assumptions and thresholds arescientifically justified and documented in the CEP/CER.
• Assess whether observed adverse-event andcomplication rates remain within predefined acceptance criteria and evaluatetheir impact on residual risk andbenefit-risk acceptability.
• Determine whether clinical evidence issufficient, identify evidence gaps, and define required PMCF and/or clinical investigation activities. Apply MDCG 2020-6 principles for sufficientclinical evidence for legacy devices, where applicable.
• Integrate and evaluate data from PMS, PMCF, PSUR, vigilance, complaints,registries, literature and clinical investigations throughout the devicelifecycle.
• Prepare/review the Summary of Safety and Clinical Performance (SSCP) in accordancewith EU MDR Article 32 and MDCG 2019-9Rev.1, including appropriate presentation of undesirableside-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 andnonconformities and support clinical evidence discussions during conformityassessment.
• 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 yearsof relevant medical-device clinical/regulatory experience, with substantialhands-on experience in Class III and/orimplantable devices.
• Demonstrated experience authoring/reviewing EU MDR CERs, defining clinicalsafety/performance endpoints and acceptance criteria, interpreting statisticalanalyses, and addressing Notified Body clinical evaluation questions.
• Strong expertise in systematic literature review, SOTA, critical appraisal, clinicalstatistics, adverse-event analysis, benefit-risk evaluation, PMS/PMCF andscientific writing.