מדעים/ביוטק
Primary purpose and function of this position:
o Lead, manage and coordinate clinical trials application (CTAs in EU
countries and IND in US) by close cooperation with assigned CROs and the
relevant functions inhouse , this includes:
§ Putting together the submission package in collaboration with
o Lead, manage and coordinate clinical trials application (CTAs in EU
countries and IND in US) by close cooperation with assigned CROs and the
relevant functions inhouse , this includes:
§ Putting together the submission package in collaboration with
לפרטים נוספים
מדעים/ביוטק
PRIMARY FUNCTIONS
The Regulatory Affair Leader focus in this position is to manage and provide
regulatory guidance, support and compliance with the all regions.
The Regulatory Affair Leader focus in this position is to manage and provide
regulatory guidance, support and compliance with the all regions.
לפרטים נוספים
מדעים/ביוטק
Primary purpose and function of this position:
The primary responsibility of the QA Device Director is to lead the
company’s Combination Product related activities, from a quality
perspective.
Major duties and responsibilities:
· Managing the Combination Product Quality System asp
The primary responsibility of the QA Device Director is to lead the
company’s Combination Product related activities, from a quality
perspective.
Major duties and responsibilities:
· Managing the Combination Product Quality System asp
לפרטים נוספים
מדעים/ביוטק
Responsibilities:
• Conducts 510(k) and CE Mark impact assessments
for product changes.
• Co-authors 510(k) submissions and significant
change notifications for product changes with moderate business impact.
• Conducts 510(k) and CE Mark impact assessments
for product changes.
• Co-authors 510(k) submissions and significant
change notifications for product changes with moderate business impact.
לפרטים נוספים
מוצר ופרויקטים
לחברה המתמחה בשירותי רגולציה ואיכות
דרוש.ה מנהל.ת פרויקטים ברישום תכשירים
רפואיים להגשה של מוצרים חדשים ותחזוקת
רישיונות קיימים
דרישות :
ניסיון בהגשת תכשירים גנריים – חובה
ניסיון בתחום רישום תוספי תזונה - יתרון
משמעותי
אנגלית ברמה גבוהה - חובה (נדרשת יכולת
תקשורת עצמאית מול גורמים בחו"ל)
דרוש.ה מנהל.ת פרויקטים ברישום תכשירים
רפואיים להגשה של מוצרים חדשים ותחזוקת
רישיונות קיימים
דרישות :
ניסיון בהגשת תכשירים גנריים – חובה
ניסיון בתחום רישום תוספי תזונה - יתרון
משמעותי
אנגלית ברמה גבוהה - חובה (נדרשת יכולת
תקשורת עצמאית מול גורמים בחו"ל)
לפרטים נוספים
מדעים/ביוטק
Position Overview
The Clinical Regulation Specialist is responsible for ensuring that
regulatory strategies and regulatory activities are effectively executed to
meet the business objectives, regulatory and legal requirements.
The Clinical Regulation Specialist is responsible for ensuring that
regulatory strategies and regulatory activities are effectively executed to
meet the business objectives, regulatory and legal requirements.
לפרטים נוספים
מדעים/ביוטק
Primary purpose and function of this position:
o o Manage and coordinate clinical trials application (CTAs in EU
countries and IND in US) by close cooperation with assigned CROs and the
relevant functions at Neuroderm, this includes:
§ Compilation of the submission package in collaboration with
o o Manage and coordinate clinical trials application (CTAs in EU
countries and IND in US) by close cooperation with assigned CROs and the
relevant functions at Neuroderm, this includes:
§ Compilation of the submission package in collaboration with
לפרטים נוספים
מדעים/ביוטק
We are in the midst of IND submission preparation for one of our cell
products with the FDA we wish to start clinical trials next year in the USA
once approved.
We need someone familiar with Gene biology or cell therapy or Biology or
micro biology
Needs QA knowledge QC knowledge – how to lead tea
products with the FDA we wish to start clinical trials next year in the USA
once approved.
We need someone familiar with Gene biology or cell therapy or Biology or
micro biology
Needs QA knowledge QC knowledge – how to lead tea
לפרטים נוספים
מדעים/ביוטק
Primary purpose and function of this position:
Responsibility for preparation and submission of branded drug-device
combination in EU and US regulatory agencies.
Major duties and responsibilities:
Establish and maintain infrastructure for file preperation and submission
Leading the cross function
Responsibility for preparation and submission of branded drug-device
combination in EU and US regulatory agencies.
Major duties and responsibilities:
Establish and maintain infrastructure for file preperation and submission
Leading the cross function
לפרטים נוספים
מדעים/ביוטק
Primary purpose and function of this position:
The Compliance and Document Control Manager is responsible for:
1. Combination Product implementation and maintenance of the Quality
Management System (QMS), and to assure continuous compliance with all quality
guidance’s, regulations and best pra
The Compliance and Document Control Manager is responsible for:
1. Combination Product implementation and maintenance of the Quality
Management System (QMS), and to assure continuous compliance with all quality
guidance’s, regulations and best pra
לפרטים נוספים
מדעים/ביוטק
Seeking for a candidate with proven experience in Labels for Medical Device
industry.
The candidate should be able to work independently, with great attention to
details, professional attitude.
Excellent grammar, editing, organization, teamwork, and written and verbal
communication skills are a
industry.
The candidate should be able to work independently, with great attention to
details, professional attitude.
Excellent grammar, editing, organization, teamwork, and written and verbal
communication skills are a
לפרטים נוספים
מדעים/ביוטק
מנהל רגולציה לחברת ציוד רפואי קטנה.
חובה: הכרה טובה מאוד של דרישות רישום ציוד
רפואי בישראל (אמ"ר) ואירופה (MDD ו- MDR).
יתרון: ידע באבטחת איכות (תקן ISO 13485).
חובה: הכרה טובה מאוד של דרישות רישום ציוד
רפואי בישראל (אמ"ר) ואירופה (MDD ו- MDR).
יתרון: ידע באבטחת איכות (תקן ISO 13485).
לפרטים נוספים
מדעים/ביוטק
Manage and provide regulatory guidance, support, and compliance for all
regions. This function will be
the recognized expert, managing projects or processes, with responsibilities
that include working with
cross-functional areas to identify, modify, or create necessary documentation
to meet the...
regions. This function will be
the recognized expert, managing projects or processes, with responsibilities
that include working with
cross-functional areas to identify, modify, or create necessary documentation
to meet the...
לפרטים נוספים