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Ad title:
Medical Device Preclinical testing, Documentation Specialist
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| Provided By:
Aptos
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Published: 29 July
/ Deadline: 27 August
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Aptos is a leading Georgian company in the aesthetic medicine and beauty industry. The history of Aptos began in 1996, when plastic surgeon Marlen Sulamanidze invented the world`s first barbed thread, laying the foundation for a new direction in aesthetic medicine—thread lifting. It was this Georgian company that obtained the first international patent and serial production license for cosmetic threads used in aesthetic procedures.
Furthermore, Aptos became the first Georgian company to receive the CE (Conformité Européenne) mark for a medical product, which allows for export across all European countries. Today, Aptos products are available on all six inhabited continents, in over 90 countries. Since 2021, Aptos products have entered the global market under the "Made in Georgia" trademark.
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 August, 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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