לוח משרות דרושים רפואה ופארמה לדוברי אנגלית

Coordinates medical affairs projects to ensure timely execution of deliverables. This includes supporting team building activities, managing timelines and deliverables, monitoring of team efforts and progress, and collaborating cross-functionally to ensure smooth program operations.

Provides operational efficiencies by implementing process improvements, providing guidance and support to team members, quickly identifying resolutions to issues, and developing communication plans to engage key stakeholders and increase program-related communication across the organization.

Project management coordination of specific medical plan deliverables, including coordinating scope development, logistics and vendor management, and coordinating logistics and content development for advisory events and trainings, as applicable. Medical projects include (but not limited to): medical studies, advisory events and meetings, medical education programs, access programs and more.

Organizes advisory boards and field medical educational activities by supporting venue selection, Key Opinion Leaders engagement, (including C2C management), applying all compliance measures and documentations, final report development, systems tracking and updates, vendor management (as applicable), and financial oversight.

Develops periodic status reports on Medical Affairs activities as needed to global, regional and local leadership.

Organizes team meetings and trainings.

Monitors budget and functions as a key partner for finance and accounting.

Manages internal approval processes that include regulatory, compliance and medical to execute projects initiated by medical affairs.

Updates of local Medical Standard Operating Procedures as required.

Performs special projects assigned by the Director of Medical Affairs as needed to advance department initiatives.

Support the medical affairs team with all activities related to contracting i.e. work with legal team and with the different vendors.

Serve as ethics and compliance champion for the department liaising between local compliance, Global team, regional/global medical compliance teams

Working together with local medical team to create Job Aids, checklists and other solutions to bridge between local Standard Operating Procedures

The individual will be responsible for the maintenance of our Quality Management System, creating and updating company SOPs and ensuring their correct and effective implementation across the various teams.
The QA/RA Manager will also support with the regulatory work being undertaken and be the direct point of contact for all regulatory and quality needs across the organization.
Job Responsibilities:
Maintain and update all company Standard Operating Procedures in our Quality Management System and ensure all departments are working according to them.
Responsible for all documentation control in QMS per internal and external regulatory requirements.
Responsible for training employees on relevant processes, and guiding them on writing all company procedures, specifications, instructions, etc.
Regulatory support and registration of the company products in various countries.

Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent V&V Engineer to join the R&D team.
Job Description: Design and implement experiments for various projects Lead verification and validation efforts for new products and components Writing protocols, reports and maintaining V&V activates Document experiments/testing methodically including result summary, analysis, and interpretation Participate in departmental tasks that include problem solving and critical/root cause analysis.

Manage several projects under his / her responsibility, per agreed milestones, timelines, and budget.
Collaborate and assist other departments to promote design and development activities.
Collaborate and supervise sub- contractors.
Develop and review protocols, reports, work instructions, test methods, etc.

Provide strategic regulatory input to early-stage projects in the field of structural heart disease
Support FDA and MDD / MDR regulatory submissions of class II and class III medical devices,
including submissions for first-in-human studies
Develop and review of design documents
Support rest-of-world regulatory submissions