Description
We are looking for Medical Reviewer (SME/SME Clinician– Medical Devices)/ Remote
NextLink Solution, a Swiss IT Consultancy Company that has been providing both IT services and IT staffing to major customers for the past 20 years, has an excellent opportunity that can take your career to the next level.
General Information:
Job Title: Medical Reviewer (SME/SME Clinician– Medical Devices)
Country: United Kingdom
Ideal Start Date:
Type of Role: Contract
Duration : 6 months
Full Time/Part Time : 100%
Is Remote Working Possible: Yes Full time
Job Description:
Position will be integral part of client organization group who are implementing European Medical Devices Regulation (MDR) for disposable and electromechanical devices. She/he will be responsible for reviewing, assessing and updating the risk management documents.
Position Responsibilities:
Assess impact of new regulations and support implementation of appropriate changes in company policy and positions on draft regulation and guidance.
To review the gap assessments of Clinical Evaluation Reports to meet MEDDEV Rev 4/MDR compliance
Review the in progress Clinical Evaluation Reports
Review IFUs and product claims for specified client products and suggest changes
Review scientific literature and clinical studies cited in CERs and assess whether there is sufficient clinical evidence
Determine if indications and claims for products are supported by clinical data
Review remediated CERs as needed prior to issuance
Assist in developing clinical study protocol design and/or post market clinical follow up
Required Experience:
* Medical Degree with super-specialty in specific therapeutic area/PhD with relevant experience/ Biomedical engineering with relevant experience
Extensive experience in using the clients products specific to a particular area
MD/PhD with relevant experience in the therapeutic area
Excellent written and verbal communication skills.
Ability to work independently with minimal supervision.
Experience with pharmaceutical/medical device industry
Knowledge of clinical study design, biostatistics and regulatory requirements for drug/device indications
Medical writing experience for at least for 3-5 years
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