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Ad title:
Medical Device Preclinical test. and Document.Sen.Specialist
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| Provided By:
Aptos
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Published: 27 May
/ Deadline: 27 June
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Aptos is a leading company in the field of aesthetics, which operates in the international market in 100 countries around the world. The company has 5 global offices in Tbilisi, Berlin, Dubai, Prague and Moscow.
For more details, please visit our website https://aptos.global/
Aptos team is looking for Medical Device Preclinical testing and Documentation Senior Specialist
Key Duties and Responsibilities:
** Planning and managing preclinical testing projects related to medical devices
** Select and communicate with external testing laboratories
** Requesting Testing Proposals and Evaluating Deliverables and Budgets and selecting the most suitable laboratory.
** Stay updated on regulatory requirements (e.g., ISO 10993-1, FDA Biocompatibility Guidance) for preclinical studies to be productively involved in the testing protocol development
** Provide administrative support to the laboratories, by providing any requested documentation and product-related information to ensure smooth testing operations.
** Monitoring development and approval of testing protocols, Testing Progress, Analyzing Interim Results, and Tracking Timelines
** Creating design history file (DHF) of the new medical device per regulatory requirements (7.3 of the ISO 13485 standard for design and development control of a medical device)
** Creation and Maintenance of the Design History File (DHF)
** Planning R&D activities to create/develop new products, process, or improve the existing ones
** Collaborating with the quality, engineering, marketing, production department
** Establish testing procedures for assessing raw materials, in-process and finished products
** Document all phases of research and development (Identifying Design Inputs and Outputs, Design review, Design verification, Design validation, Design transfer).
** Collaboration with Design and Development Teams
** Participate in preparing and conducting various scientific research projects
** Conduct research through scientific publications that can lead to new ideas and analyzing the results
Requirements and Qualifications:
** Minimum master`s degree in life sciences, chemistry, pharmacy, science field
** Experience in scientific field is preferred
** Working experience in related fields
** Analytical skills and able to interpret data
** Attention to detail
** Experience creating and writing document.
** Advanced knowledge of the English language, both written and verbal
Job type/working hours:
Full time position. Working days and hours are Monday-Friday, from 09:30 to 18:00.
Other Duties:
Please note that the job description may not include the full list of activities, duties or responsibilities required of a person working in this position.
If you feel you meet the requirements and are the right candidate for this position, please apply and send your CV to Hr@aptos.ge no later than 27 June, 2025. Only shortlisted candidates will be contacted for an interview.
In "subject", it is required to mention position name - Medical Device Preclinical testing and Documentation Senior Specialist
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