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EUMDR Specialist

5.00 to 10.00 Years   Pune   04 May, 2020
GLOINNT
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryCement / Building Material
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

  • Understands the regulatory landscape and Supports the cross functional teams with regulatory guidance during the design control phases of a new product or product engineering phases .
  • Responsible for the planning, coordination and preparation of document packages for regulatory submission across different projects.
  • Responsible for implementation of EU MDR related deliverables across product lines.
  • Actively participating in GAP analysis between MDD and MDR thereby identifying gaps in the current devices
  • Provides guidance on global compliance, such as CE Marking and product registrations to extend possible
  • Experience in managing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs) for EU MDR compliance will be added advantage.
  • Actively involved in the Technical file preparation of various Class 2 and 3 devices which will have to be MDR compliant by May26, .
  • Preparing Post market Technical file and implementing post market requirement for MDR
  • Must have experience with successful preparation of 510(k), PMA, or international documents for product approvals
  • Strong understanding of Design Control processes including standards like ISO13485:2016, IEC 62304, ISO 14971 is must
  • Excellent working knowledge of medical device regulations FDA ( 21 CFR) , MDD, other global laws and regulations will be desirable.
,

Keyskills :
iec62304 eu iso13485 regulatoryaffairs iso14971 cemarking productengineering gapanalysis globalcompliance tatementsofworksow

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