מדעים/ביוטק
The Manager of Regulatory Affairs leads and coordinates the process of local
and international regulatory submissions and maintaining of current company
certifications, along with reviewing, coordinating and maintaining of company
controlled documents (PLM SW) in accordance with all applicable in
and international regulatory submissions and maintaining of current company
certifications, along with reviewing, coordinating and maintaining of company
controlled documents (PLM SW) in accordance with all applicable in
לפרטים נוספים
מדעים/ביוטק
Primary purpose and function of this position:
· Lead & Support regulatory aspects of device and drug/device combination
elements throught the einter product life cycle .
· Build Regulatory strategy for development and submission along the project
· Review device related protocols/reports to ensure
· Lead & Support regulatory aspects of device and drug/device combination
elements throught the einter product life cycle .
· Build Regulatory strategy for development and submission along the project
· Review device related protocols/reports to ensure
לפרטים נוספים
מדעים/ביוטק
Regulatory Affairs Specialist with a fast growing, global, Class II US
Class III (EU) medical device company, responsible for working
internationally with cross-functional teams to support regulatory
license/registrations for commercialized devices under the direction of
senior RA personnel.
Class III (EU) medical device company, responsible for working
internationally with cross-functional teams to support regulatory
license/registrations for commercialized devices under the direction of
senior RA personnel.
לפרטים נוספים
מדעים/ביוטק
The technology is based on an innovative new form factor for the use of
Magnetic Resonance (MRI) that enables accurate and rapid surface imaging for
real-time assessment of tissue microstructure in the operating room.
The right person for this role will maintain and manage the QA system and
docu
Magnetic Resonance (MRI) that enables accurate and rapid surface imaging for
real-time assessment of tissue microstructure in the operating room.
The right person for this role will maintain and manage the QA system and
docu
לפרטים נוספים
מדעים/ביוטק
Pre-Clinical & Clinical RA Director
Department: Regulatory Affairs
Reports to: VP RA
Primary purpose and function of this position:
Support pre-clinical and clinical aspects of product development with focus
on authoring/review of M4 & M5 in NDA/MAA and any other regulatory documents
(such as CTA/
Department: Regulatory Affairs
Reports to: VP RA
Primary purpose and function of this position:
Support pre-clinical and clinical aspects of product development with focus
on authoring/review of M4 & M5 in NDA/MAA and any other regulatory documents
(such as CTA/
לפרטים נוספים
מדעים/ביוטק
Role & Responsibilities:
Supporting the activities and processes required to assure that products
designed, manufactured and distributed are in compliance with all applicable
regulatory requirements.
Assisting in the planning and preparation of submissions to obtain regulatory
approvals for new
Supporting the activities and processes required to assure that products
designed, manufactured and distributed are in compliance with all applicable
regulatory requirements.
Assisting in the planning and preparation of submissions to obtain regulatory
approvals for new
לפרטים נוספים
מדעים/ביוטק
לחברה מובילה בתחום ה- Medical Devices דרוש/ה
מנהל/ת רגולציה בכיר/ה RA
התפקיד כולל:
תמיכה ברישום של מוצרים קיימים, אחריות על
עמידה בתקנות ובסטנדרטים גלובליים, ניהול DHF
כולל הכנת TF לרישום CE
תמיכת QA / RA בפרויקטי פיתוח
דרישות:
* מינ' 8 שנות ניסיון ב- RA בתחום ה- Medical Devices
class III, תה
מנהל/ת רגולציה בכיר/ה RA
התפקיד כולל:
תמיכה ברישום של מוצרים קיימים, אחריות על
עמידה בתקנות ובסטנדרטים גלובליים, ניהול DHF
כולל הכנת TF לרישום CE
תמיכת QA / RA בפרויקטי פיתוח
דרישות:
* מינ' 8 שנות ניסיון ב- RA בתחום ה- Medical Devices
class III, תה
לפרטים נוספים