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Philips Clinical Analyst in Bangalore, India

null Clinical Analyst-ICAP

Key pointers- Research methodology -clinical study design- Advance image processing-Medical device on software-Bio statistics- Medical scientific writer-Regulatory knowledge

Position summary:

The Clinical Analyst ICAP is responsible for the clinical evaluation of our medical devices. This involves the assessment, creation & documentation of the evidence to substantiate clinical safety and performance, equivalence and our product claims, on the basis of published clinical data and our own performance, post-market safety and clinical data. As part of a cross-functional team you collaborate with key stakeholders to help bring our products successfully to market.

Responsibilities:

As Clinical Analyst, you provide the project teams with clinical data available in the medical scientific literature and expertise to weigh the evidence as part of the evidence package on the safety and performance of our medical devices. You will support marketing to define strong claims to position our solutions in the market. You will support (pre-) development with the selection, creation and performance evaluation of the technology involved. You will ensure that this data is delivered on-time & the product submission is first time right.

Key areas of responsibility:

  • Develop the clinical evaluation strategy for our clinical applications

  • Responsible for the deliverables as defined in the clinical evaluation procedure in compliance with the new Medical Device Regulations (MDR)

  • Create evidence to support regulatory submissions for all regions

  • Responsible to deliver on-time as defined by the project team

  • Support R&D and clinical science by technology selection, creation and assessment

  • Support project teams by providing analysis of clinical data, post-market safety data, and reviews of medical scientific literature

  • Consult with marketing, Q&R and legal to support claim substantiation

  • Bridging technology strengths and weaknesses of our solutions to available (public) available clinical evidence

  • Maintenance of the evidence and related documentation as planned in our Post Market Surveillance & Post-Market Clinical Follow-up activities

Requirements:

  • 9-15 Years of experience

  • Masters or PHD degree with an understanding of research methodologies & clinical study design according to good clinical practices (GCP) and demonstrated experience in a relevant technical domain such as advanced image processing, Artificial Intelligence, or nuclear medicine

  • Basic understanding of Biostatistics

  • Basic understanding of Advanced Visualization Solutions

  • Experience as a medical/scientific writer or equivalent

  • Strong analytical skills

  • A clear and concise writing style

  • Regulatory process knowledge

  • Ability to work independently & as a member of the team

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