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