Regulatory Affairs Intern

4 weeks ago


mumbai, India haystack Analytics Full time
Who arewe Based out ofIIT Bombay HaystackAnalytics is a HealthTech company creatingclinical genomics products which enable diagnostic labs andhospitals to offer accurate and personalized diagnostics. Supportedby Indias most respected science agencies (DST BIRAC DBT) wecreated and launched a portfolio of products to offer genomics ininfectious diseases. Our genomics based diagnostic solution forTuberculosis was recognized as one of top innovations supported byBIRAC in the past 10 years and was launched by the Prime Ministerof India in the BIRAC Showcase event in Delhi2022.
Responsibilities
  • Supportin creating regulatory and quality policy plan as needed internallyand externally
  • Work with internal personnel andexternal agencies to implement relevant regulatoryrequirements
  • Maintain and submit regular followup documentation to regulatory/ quality agencies and participate inaudits as needed
  • Document review andpreparation of submissiondossiers
Requirement
  • Goodunderstanding of the latest regulatoryaffairs
  • Ability to quickly prioritize andexecute tasks
  • Strong analytical skills andattention to details
  • Strong documentationskills

regulatoryaffairs,document review,medicaldevices,documentation



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