Clinical Evaluation Researcher

2 months ago

Ahmedabad, India Mantras2Success consultants Full time

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 4.
- 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 14155.
- Expertise in writing regulatory documents like Clinical evaluation reports(CER) pertaining to medical devices(end to end) as per MedDev 2.7.1 Rev 4.
- How to work on Gap analysis of CER's according to MEDDEV 2.7.1 Rev 4.
- 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 1-2 years in CER writing experience with solid knowledge of EU MDR Med Dev 2.7/1, rev 4.
- 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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