Executive (Kawal)

Executive (Kawal)

16 Aug
|
Recognized
|
Kawal

16 Aug

Recognized

Kawal

· 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.





Advantages

· Fresh Perspectives



· Enhanced Skills and Expertise



· Increased Productivity



· Improved Morale



· Broadened Network



· Diversity and Inclusion



· Knowledge Transfer





📌 Executive (Kawal)
🏢 Recognized
📍 Kawal

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