UG :- Any UG
PG :- Any PG
No of position :- ( )
Post :- 13th Jan 2021
Job Position: Medical Reviewer (SME/SME Clinician– Medical Devices)
Location: Remote
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 like
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:
• 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
Desirable experience:
• Experience with MS Project, MS Office
Educational Qualification: Medical Degree with super-specialty in specific therapeutic area/PhD with relevant experience/ Biomedical engineering with relevant experience
Total working experience: 10-12 Years
Relevant experience: 3-5 Years