לוח משרות דרושים רישום / רגולציה רפואית משרה מלאה, לחיפוש זה נמצאו 43 משרות, מתוכן 20 בלוח החם חינם!

Required Pharmacist for Regulatory Affairs and Pharmacovigilance Dept.
Reporting side effects and adverse events to the relevant regulatory and health authorities. Review and analysis of relevant literature, processing and recording data.
מס' משרה JB-73.

We are looking for a Country Approval Specialist for our regulatory department in PPD.

Required Regulatory Submission Specialist.

Required Director, International Regulatory Affairs.
Working in partnership with the Head for International Regulatory Affairs:
Provide strategic advice to project teams with respect to Europe and Israel.
Assist and manage MAA submissions and NDA as necessary.
Develop briefing packages for meetings with global health authorities (country specific competent authorities and EMA as necessary.
Develop regulatory timelines.
Lead the compilation of key regulatory documents and other assigned tasks within the established timelines.
Ensure appropriate scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs.
Identify and assess regulatory risks for assigned projects or
Serve as point of contact for functional areas and as a member of clinical project team.
Define regulatory expectations for program teams.
Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
Develop strategies and drafts and/or review responses and other documents intended for submission to global health authorities and Ethic Committees
Manage and oversee vendor(s),
Ensure regulatory compliance with pre- and post-approval filing and reporting requirements.
Prepare and deliver effective presentations for external and internal.
Primary contact for regulatory agencies relevant to assigned projects or programs.
Prepare and participate and contribute in Health Authority.
Up to 20% international travel.

Required Quality Team Lead.
Requirements:
Education: A formal Engineering degree in Chemical, Industrial, Mechanical or a B.Sc. in the life Sciences from a known academic institution; A CQE certification and or significant practical experience in the medical device arena are advantageous.
Experience: Minimum three years in the areas of validation and quality engineering in the medical device or pharmaceutical industry.
Languages: Hebrew- speaking, reading, and writing - at a mother tongue level.
English- speaking, reading, and writing - fluent.

The company turns the smartphone camera into a clinical-grade medical device, improving access to healthcare across the globe. Our products are geared towards consumers as well as healthcare partners. As we rapidly grow we are looking for an RA Specialist to join our RA/QA team. The RA Specialist is responsible for assisting in planning, coordinating, and conducting clinical research projects. Ensuring compliance with research protocols, adherence to clinical objectives, and supporting the smooth operation of clinical studies. A major project is supporting the transition of the company to a new European regulation system: MDR, IVDR. As RA Specialist you will write submissions, fill out all forms, work and Interact with product managers, production and development teams. 
Role & Responsibilities: 
* Supporting the activities and processes required to assure that products 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 and modified medical devices. 
* Preparation for tests, supporting engineering changes in the product/quality system. 
* Prep submission including 510(K), technical files 
* AMAR submissions 
* Notifications of changes 
* Learning new standards and training relevant staff.* Learning new standards and training relevant staff

Required Regulatory Affairs (RA) Specialist.
Supporting the activities and processes required to assure that products 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 and modified medical devices.
Preparation for tests, supporting engineering changes in the product/quality system.
Prep submission including 510(K), technical files.
AMAR submissions.
Notifications of changes.
Learning new standards and training relevant staff.

Required Regulatory Manager.
Ownership of all regulatory aspects of the companys activities including:
Managing of regulatory strategy and FDA submissions.
Preparation of pre-submission packages.
Submission of 510k/De Novo 510k.
Ensuring adherence to relevant guidelines and regulations .
Providing regulatory guidance for product development and other company activities.