2.0 - 7.0 years

12 - 18 Lacs

pune

Work from Office

****If interested then kindly apply on below link**** https://noccarc.notion.site/clinicalresearcherspecialist About Role: As a Clinical Research Specialist at Noccarc, you will be the in-house doctor who brings the ICU to our R&D floor. You will shape next-generation critical care devices by defining clinical requirements, guiding product development, driving validation and trials, benchmarking against global standards, and leading medical writing and research that advance both our products and the field of critical care. To know more about Noccarc visit: www.noccarc.com Noccarc office video: https://youtu.be/OoeD10ckrdU Role: Clinical Research Specialist Location: Pune (5 days WFO) Reporting To: CTO Mandatory Requirement: MBBS with 2+ years of ICU Key Responsibilities: (A) Product Definition & Development Provide clinical leadership by embedding frontline critical care expertise into product development. Work with product managers, system architects, and engineers to define clinical requirements, performance standards, and safety specifications for advanced critical care devices. Translate real-world ICU/OT workflows and customer pain points into evidence-based design inputs for product development. Guide the development of clinical algorithms, physiological models, and therapy workflows with engineering teams. Participate in risk assessment, usability analysis, and hazard evaluation from a clinical perspective. Provide structured clinical feedback during design reviews, prototyping, and verification phases to ensure alignment with international best practices. Support decision-making on trade-offs between usability, patient safety, clinical performance, and technical feasibility. (B) Product Testing & Validation Design and coordinate ex-vivo, simulation, and clinical validation studies. Manage clinical validation/ trials, including protocol design, site selection, investigator coordination, and patient studies. Conduct comparative benchmarking of Noccarc devices with competitor products on performance, usability, and clinical outcomes. Prepare and maintain Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and PMCF documents in compliance with EU MDR and other standards. Ensure validation data is scientifically robust and supports regulatory submissions. (C) Medical Writing & Research Publications Author scientific papers, whitepapers, abstracts, and conference presentations in collaboration with hospitals and research partners. Write clinical manuals, usage guides, and training content for customers and internal teams. Contribute clinical documentation for regulatory submissions. Requirements: (A) Education MBBS degree (mandatory). Postgraduate degree in Critical Care, Anesthesiology, Pulmonology, or equivalent preferred. (B) Experience 2+ years of ICU clinical experience in a reputed hospital (Mandatory) Prior exposure to clinical research, medical devices, is a plus. Experience in clinical trials, medical writing, or regulatory documentation (CER, CEP, PMCF) preferred. (C) Skills Strong understanding of human physiology, respiratory therapy, and critical care workflows. Proficiency in interpreting clinical literature and writing scientific documents. Ability to define and evaluate product performance in real-world ICU settings. Strong communication skills with ability to influence both clinical and engineering teams. Why Join Us? Work directly with the founders and R&D leads High ownership, fast learning curve, and direct impact on product outcomes ESOPs for high performers

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