לוח משרות דרושים רפואה ופארמה משרה מלאה

Take on a pivotal role as a Regulatory Affairs Specialist in Israel, supporting both pre-market and post-market regulatory activities within our companys Diabetes spin-off organization. In this role, you will be a key partner to cross-functional teams, ensuring regulatory compliance across the product lifecycle while enabling timely market access and sustaining ongoing business operations. This is an exciting opportunity to contribute to a growing, agile organization focused on innovation and delivering impactful solutions for people living with diabetes.
This position is an exciting opportunity to work with our company's Diabetes business. our company has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across our company, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
Responsibilities may include the following and other duties may be assigned:
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.

We are seeking a talented and motivated Affera and Single Shot Therapy Account Consultant to join our team to further drive the growth of the business.
Reporting to the operating unit this role is critical in providing expert clinical and technical support and training to physicians and Electrophysiology Lab Staff on the optimal use of the Affera Mapping and Ablation System and the use of our single shot technologies (Cryo and PulseSelect).
Responsibilities may include the following and other duties may be assigned:
Provide proficient clinical and technical assistance to physicians and EP Lab Staff on the use of the Affera Mapping and Ablation System and related equipment (Generators, SW functionalities, pump and accessories). Both Single shot technologies - Cryo and PulseSelect.
Provide in-service training to introduce new technologies to various hospital stakeholders and ensure technology acceptance.
Play an active role in the planning and effective installation of the Affera Mapping and Ablation System and efficiently collaborate with the technical department.
Share clinical best practices with colleagues to continuously optimize customer experience.
Work with field service engineers on technical troubleshooting.
Support sales processes in dedicated accounts .
Participate in regional and occasionally international congresses, symposia and workshops.

we are looking for a Associate Clinical Liaison.
In this role, you will
Provide initial and ongoing training to new and existing iTero customers.
Utilize technology to deliver virtual classroom training and training support.
Effectively implement lesson plans for training sessions.
Independently and efficiently book travel as needed and within company guidelines.
Provide a weekly report of completed trainings.
Manage business expenses and expense reporting in a timely and accurate manner.
Provide ongoing support to foster positive long-term relationships with customers.
Troubleshoot independently and with internal teams to address customer service issues.

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities:
Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Ensure timely license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Monitor and document post marketing activities, analysis of trends, vigilance processes.
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes