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 1-3 years CER writing experience with solid knowledge of Med Dev 2.7/1, rev 4.

·     At least 1-3 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