Clinical Evaluation Researcher - Ahmedabad, India - Mantras2Success consultants

Mantras2Success consultants
Mantras2Success consultants
Verified Company
Ahmedabad, India

4 weeks ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description
Opening: 1 Nos.

Job ID: 63886


Employment Type:
Full Time


Reference:
Work Experience: 2.0 Year(s) To 3.0 Year(s)

CTC Salary: 3.00 LPA TO 3.60 LPA

Function:
Pharma / Biotech / Healthcare / Medical / R&D


Industry:
Pharma/Biotech/Clinical Research


Qualification:
B.Sc - General; B.Tech/B.E. - Bio-Chemistry/Bio-Technology


Location:


  • Ahmedabad
**- Knowledge of Clinical Evaluation Reports (CER) as per EU MDR, MEDDEV 2.7/1 Rev - Perform the risk benefit analysis as per ISO 14971 to demonstrate the medical device benefits outweighed the residual risk.

  • Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
  • Literature reviews, Appraisal of literature article for data suitability and data contribution, Writing literature summary.
  • Knowledge of Clinical Evidence Summaries & Summarizing and analyzing data from clinical studies.
  • Consulting, Editing statistical and clinical reports, review of medical journals and technical reports.
  • Good knowledge on EU MDR, ISO 1415
  • Expertise in writing regulatory documents like Clinical evaluation reports(CER) pertaining to medical devices(end to end) as per MedDev 2.7.1 Rev
  • How to work on Gap analysis of CER's according to MEDDEV 2.7.1 Rev
  • Preparing literature search strategy,Screening and summarization by using PubMed,Google Scholar Writing Manuscripts(Research paper, Review articles,abstracts).
  • Experience in Client Communication and Status Reporting.
  • Assisting with other clinical, regulatory, quality and projects as assigned.
  • Responsible for acquiring, interpreting, analyzing and drawing conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices specifically Ophthalmic Products.
  • Strong knowledge and understanding of Good Clinical Practices and regulatory standards

Qualification:


  • 2 3 years in clinical, regulatory, quality work experience or 12 years in CER writing experience with solid knowledge of EU MDR Med Dev 2.7/1, rev Bachelor Degree or Master's Degree or PhD (preferred) in a scientific discipline.
  • Able to read, analyze and implement regulations, standards and guidance
  • Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)

Key Skills:


  • Clinical Evaluation Reports
  • Clinical Evidence

Company Profile:

One of the leading manufacturers of surgical appraratus especially in the Opthalmic field. One of the biggest IOL Manufacturer from INDIA.
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