Executive

· To develop and write clinical evaluation reports (CER) for pre- and post-market devices, while ensuring consistency with regulations, quality standards, commitments and goals. · Writing coherent, convincing CERs by organizing and evaluating large amounts of scientific/clinical/medical data. · Managing CER writing by planning, identifying, appraising and analyzing clinical data then writing the CER including conclusions based on expert knowledge. · Ensuring quality by following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust CERs and other documents · Assisting with other clinical, regulatory, quality and engineering projects as assigned · Responsible to acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices · Responsible to communicate scientific content in a clear, concise manner · Other duties as assigned Requirements · Must be focused, efficient, detail oriented and able to work independently. · Able to read, analyze and implement regulations, standards and guidance. · Demonstrated ability to manage projects (take minutes, multi-task, prioritize and ensure reliability and quality while executing projects on time and on budget). · Strong written and oral communication skills. · Bachelor's or Master’s Degree or PhD (preferred) in a scientific discipline. · At least 3+ years CER writing experience with solid knowledge of Med Dev 2.7/1, rev 4. · At least 3+ years clinical, regulatory, quality and/or engineering work experience. · Able to productively interact with teams including corporate executives, research sites and research subjects. · Advanced computer skills with Word, Excel, PowerPoint, etc. Benefits · Fresh Perspectives · Enhanced Skills and Expertise · Increased Productivity · Improved Morale · Broadened Network · Diversity and Inclusion · Knowledge Transfer Requirements · Must be focused, efficient, detail oriented and able to work independently. · Able to read, analyze and implement regulations, standards and guidance. · Demonstrated ability to manage projects (take minutes, multi-task, prioritize and ensure reliability and quality while executing projects on time and on budget). · Strong written and oral communication skills. · Bachelor's or Master’s Degree or PhD (preferred) in a scientific discipline. · At least 3+ years CER writing experience with solid knowledge of Med Dev 2.7/1, rev 4. · At least 3+ years clinical, regulatory, quality and/or engineering work experience. · Able to productively interact with teams including corporate executives, research sites and research subjects. · Advanced computer skills with Word, Excel, PowerPoint, etc. Benefits · Fresh Perspectives · Enhanced Skills and Expertise · Increased Productivity · Improved Morale · Broadened Network · Diversity and Inclusion · Knowledge Transfer