מדעים/ביוטק
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
• 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
לפרטים נוספים
מדעים/ביוטק
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
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
לפרטים נוספים
מדעים/ביוטק
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
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
לפרטים נוספים
מדעים/ביוטק
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.
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.
לפרטים נוספים
מדעים/ביוטק
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.
• 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.
לפרטים נוספים
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
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
לפרטים נוספים
מדעים/ביוטק
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
• 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
לפרטים נוספים