Vacancy expired!
- Perform comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies and stay informed about applicable clinical landscapes and trends.
- Combine an understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge to support Regulatory Affairs submissions for CE marking of new devices and maintaining CE marks for existing devices.
- Extracts data from included studies, interpret study results, synthesizes literature, and prepares summaries into formal reports.
- Organizes clinical data from literature into references, graphics, tables, and data listings
- Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
- Manage CER timelines required by product development teams and global regulatory bodies by utilizing the appropriate project management tools.
- Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, and Regulatory Affairs relating to the CER process to identify the necessary clinical and technical information for the assigned project.
- Ensure documents are produced per procedures, internal and external guidelines, and electronic templates
- May author protocols and routine clinical study progress reports.
- Masters degree required, preferably with a scientific emphasis.
- PhD preferred or 5 years of documented scientific/research experience.
- 2 years experience in clinical evaluation report writing (CER) in the medical device industry is required.
- Strong knowledge of orthopedic medical and surgical terminology
- Experience writing study protocols and final study reports
- Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics)
- Working knowledge of MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745
- Working knowledge of ISO 14155.
- Working knowledge of biomedical databases (i.e., Pubmed, Embase)
- A thorough understanding of the National Library of Medicines Medical Subject Headings (MeSH)
- Proficient in document development and management software skills: Word/ Excel/ PowerPoint.
Vacancy expired!