Remote Medical Writer

                                 Remote Medical Writer - Medical Device company- 12 Months contract

• Desired experience in medical devices, clinical regulatory documents, EU-MDR transitions/remediation activities and CER writing.
• Provides advanced scientific writing expertise for multiple projects in therapeutic areas of Acute Ischemic and Hemorrhagic Stroke.
• Interfaces with other functional teams (e.g. , Regulatory Affairs, Biostatistics, Clinical Affairs, Medical Safety, Design Quality, R&D, Post Market Complaints ), ensuring successful preparation of high quality submission-ready documents to support global market access strategy under EU-MDR remediations.
• The position interfaces with CRO’s and External consultants to ensure timely submission of files Serves as the scientific writing content expert for the deliverables including authorship and evaluation of data for product and similar competitor devices.
• Screening and summarizing literature for relevant clinical data. Ensuring timely production of high quality CERs, CEPs, SSCPs, PMCF Plans and PMCF Reports and other relevant submission documents.

• Knowledge of working in a quality environment Must meet the following requirements for consideration
• - 5 years of regulatory writing experience, with some exposure to medical devices.
• - A MD, PhD in Biomedical Engineering or similar degree preferred, a Bachelors degree with clinical research exposure required.
• - 5+ years of CER writing experience in a medical device company, CRO, or agency preferred
• - Advanced knowledge of 510(k), MedDEV 2.7.1 Rev 4, MDR, and other relevant medical device regulations.
• Vascular Experience preferred