לוח משרות דרושים רישום / רגולציה רפואית משרה מלאה

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. Job Description: Managing the post market RA team which handles the following activities: · Support design and post market compliance of products from a regulatory perspective · Handling Vigilance, MDR and authorities’ inquiries of complaints · Support the investigation process from a regulatory perspective · Responsible for managing product field action · Responsible on regulatory assessment related QMS process · Responsible of company’s PSUR Direct manager: VP of R&A

The Regulatory Affairs Post-Market Specialist leads and executes key post-market activities to ensure compliance with the Israeli Ministry of Health (AMAR) and requirements. This includes managing adverse event (vigilance) reporting, coordinating Field Safety Corrective Actions (FSCAs), and serving as a regulatory contact for post-market issues in Israel. The role involves close collaboration with cross-functional and global teams to maintain the highest standards of quality and patient safety.

Responsibilities may include the following and other duties may be assigned:

Lead the execution and follow-up of Field Safety Corrective Actions (FSCAs) including coordination with internal teams, customers, and submission to the Ministry of Health (MOH)
Manage the adverse event (vigilance) reporting process to the Israeli MOH, ensuring timely and accurate submissions in accordance with local regulatory timelines and guidelines
Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities
Serve as a regulatory contact for the Israeli MOH on all post-market issues, including adverse events, recalls, field actions, and periodic updates
Stay up to date with changes in AMAR regulations, MOH guidelines, and industry standards, and communicate potential impacts to management and relevant teams
Participate in the local recall committee or crisis response team in the event of product safety issues requiring urgent action
Provide training to local teams on vigilance reporting, complaint handling, and FSCA procedures to ensure consistent and compliant practices

R39882

The Regulatory Affairs Specialist will be part of the Regulatory team at the Caesarea site, reporting to Regulatory Affairs Manager, supporting ongoing activities as required. The individual will serve as Regulatory Affairs representative in various workstreams.
Responsibilities may include the following and other duties may be assigned:

Regulatory assessments and registrations worldwide
Write, update and maintain technical files for Class I, IIa and IIb
Support global regulatory requirements and submissions
Support QMS changes, PMS and CAPA activities related to the regulatory field
Responsible for labeling requirements and compliance
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.

R44331

we invite you to join us! As Medical Affairs Manager (MAM), you are a key member of the Israeli Medical team and represent an office but also a field and customer-focused role, enabling medically oriented interaction with internal and external stakeholders based on individual contacts, educational events, and medical projects. You will provide expert medical support, including educating the local sales and marketing team as needed. You will be an expert on the disease areas under their responsibility and will ensure their knowledge is current and thorough. You will lead a Medical Customer Engagement Strategy and the Medical Affairs project plan for Medical Launch Excellence and successful Life Cycle Management, fully in line with brand strategies and company objectives, to meet the predefined targets of the Affiliate medical affairs department.
Responsibilities:

*  Medical knowledge and expertise regarding the therapeutic area and the product for which you are responsible, including elements such as staying updated on the medical developments in the field, clinical and research information and sharing the knowledge with the relevant team members
* Working in close collaboration and being part of a cross functional team with the Marketing and Market Access Departments
* Participating in national and international partners' meetings
* Acting as focal point for medical know-how by regularly reviewing clinical articles and attending scientific and medical meetings and conferences
* Providing medical and scientific training and/or support to other team members across all company functions
* Evaluating scientific materials, preparing for lectures and presentations
* Providing medical information and, if necessary, forward medical questions to partners abroad
* Maintaining scientific and medical contact with key opinion leaders and decision makers
* Writing an annual medical plan together with the Medical Lead/ Medical Director and in coordination with the marketing department
* Proactively supporting business development team and processes
* Working in collaboration with the regulatory department
* Participating in the process for inclusion of technologies in the health basket
* Leading Early Access Programs, compassionate use programs and clinical trials
* Reporting any safety information received to the Pharmacovigilance Department
* Working in accordance with all compliance rules with local and global partners' regulatory guidelines
City:
Petah Tikva