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מדעים/ביוטק

Regulatory Affairs Specialist (RA specialist)

757372
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Support preparation of worldwide regulatory strategies, submissions,
registration and documentation 
• Perform coordination and preparation of documents packages for regulatory
submissions from all areas of the company (collaborate with Marketing,
Clinical

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Regulatory Affairs Engineer (Design control)

253321
A medical device company that develops and manufactures innovative medical
equipment.
• Support design and development of products from a regulatory perspective
including verification and validation protocol and report review 
• Compiling and ongoing maintenance of RA procedures
• Compiling and on

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Quality Assurance and Regulatory Engineer

346705
The QA and RA Engineer is responsible for the planning and execution of
quality assurance activities ensuring that processes, products and services
meet all external and internal quality requirements and are in compliance
with regulations. 
QA & RA Engineer supports management and team in all asp

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מדעים/ביוטק

Clinical, Quality and regulatory affairs manager.

716761
Responsibilities
1. Take part in the regulatory strategy definition
2. Implement quality SOPs in the company
3. Assist with QA on-going tasks
4. Take charge of the planning and execution of the clinical studies
5. Prepare regulatory file submission
6. Establish a Scientific Advisory Board
7.

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Regulation Manager

780483
Requirements & Skills

• 6-8  years in Regulatory Affairs; recognized regulatory experience  in
the biotech industry 
o cell therapy experience – highly preferred
o biological compounds - gene therapy, monoclonal antibodies, blood products-
advantage over chemical compounds experience
• BSc., MSc.

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מדעים/ביוטק
- Managing the company’s quality system in accordance with its established
procedures and in compliance with ISO13485:2016 and relevant regulations
(MDR, CFR, SOR, etc.)


- Quality representative to management and leading management reviews


- Guiding and instructing company management in applic

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Reliability Engineer

753034
Requirements:
• Education- Engineering degree, CRE certification - advantage
• At least 5 years experience in Reliability engineering,
• Experience with airborne systems - advantage
• Knowledge of: MIL-HDBK-217F, MIL-HDBK-472, MIL-HDBK-781, ARP 4761, ARP
4754. 
• Experience with Environmental and r

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