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Clinical Specialist

3.00 to 7.00 Years   Pune   07 Nov, 2019
Capgemini
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaNursing
EmploymentTypeFull-time

Job Description

Short DescriptionClinical Specialist 3 to 7 years PuneQualificationsBE/B.Tech/ME/M.Tech/MCA/MSJob ResponsibilitiesKey Responsibilities:

  • Write CERs by evaluating scientific literature, reviewing hazard analyses and other risk documents, reviewing product complaint data, analyzing scientific data, and staying abreast of current clinical practice. Your effort and leadership support product approval, indication expansion, and mandated post-market requirements.
  • Provide clinical input to support claims and statements for new product development, post market surveillance, recertification, and business development.
  • Interact with regulatory agencies as needed, by providing audit support or addressing clinical queries in support of product safety and performance.
  • Manage CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
  • Provide input into hazard analyses, product failure modes & effects analyses, and directions for use for assessment of potential harms and support of product safety and performance.
  • Supports implementation of functional excellence initiatives.
  • Encourages problem-solving processes leading to leveragability of solutions across divisions.
Need exp in clinical evalution reports, risk assesment, biostatistics, databases Pubmed, ovid, embase, Medlineendnote ,

Keyskills :
marketingnursing salesdatabase administration risk assessmentproject management product developmentregulatory agencies

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