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

Meril Hiring for Sr. Officer/ Jr. Executive at Pardi, Gujarat, India Full Time

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