Description
Medical Reviewer – Clinical SME – Remote
Initial 6 Month Contract – May lead to permanent role.
Overview
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 and overall document sign-off.
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.
Essential Criteria
- Medical Degree with super-specialty in specific therapeutic area/PhD with relevant experience/ Biomedical engineering with relevant experience.
- Total working experience: 10-12 Years
- Medical writing experience for at least for 3-5 years