לוח משרות דרושים רגולציה

offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.
As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.
Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!
As a QP Pharmacist, you will be Responsible for ensuring compliance with all ongoing control processes designed to guarantee that products are not released to the market until it is determined that their quality matches the approved specifications in the registration file.

In addition, responsible for quality processes in the regulatory affairs department that will be adapted to international standards, local regulations, where applicable, and the organizational quality level established for medical products.

This is a temporary position for 8 months.
Responsibilities
Qualified Person Responsible Pharmacist of the importer.
Ensuring Compliance with Israeli Regulations: The QP is responsible for ensuring that all pharmaceutical products meet the standards set forth by Israel's Ministry of Health (MoH) and other relevant regulatory authorities. Review the product batch release documentation and authorizing or rejecting the batch release to the market. Certification of Compliance: to certify that each batch of the product has been produced and tested according to relevant specifications and regulations before it reaches the market.
Accompanying regulatory audits and being responsible for regulatory knowledge, document control, writing procedures, maintaining and updating relevant professional literature, and assisting in planning training activities in the field.
Liaison with the MOH and working according to the MOH guidelines, including immediate reporting of any complaint or recall if necessary.
Responsible for batch releases of registered and non-registered products.
Review PQRs and full batch records provided by the partners.
Execution of additional supervisors instructions and tasks accordingly.

Who We Are At Cross River, we're building the financial infrastructure that powers global innovation. With our cutting-edge suite of embedded payments, cards, and lending solutions, we enable millions of businesses and consumers to transact seamlessly and securely. With 900+ employees worldwide and an R&D center of over 160 employees in Jerusalem – we’re reshaping how financial technology is developed and delivered

The Role:
We’re looking for an IT Compliance Associate to join our Technology team and help ensure our systems, vendors, and internal processes meet legal, regulatory, and security standards. In this role, you’ll support the design and implementation of an effective IT compliance framework, manage access controls, assess risk, and guide teams in upholding compliance across the organization. You’ll also help shape policies, identify gaps, and drive remediation efforts with cross-functional stakeholders. This is a collaborative, detail-oriented position with room for growth in the cybersecurity and compliance domain

Who You Are:

* A sharp, analytical thinker with high attention to detail
* Collaborative, reliable, and able to thrive in a structured environment
* Comfortable analyzing complex data, identifying risk, and advising on controls
* Driven by doing things ethically, legally, and right the first time

What You’ll Actually Be Doing:

* Native-level fluency in both English and Hebrew (written and verbal)— Must
* Develop and maintain an effective IT compliance program
* Conduct risk assessments on internal processes and systems
* Lead access recertification and vendor risk assessment processes
* Draft, manage, and update internal compliance policies and documentation
* Review vendor documentation for regulatory and security alignment
* Analyze data, identify compliance gaps, and implement remedial actions
* Prepare reports, dashboards, and compliance summaries for internal stakeholders
* Organize and contribute to quarterly Cyber Steering Presentations

Why You’ll Love Working Here:
Flexible hybrid work model: three days a week at our Jerusalem office Monthly wellness reimbursement – from therapy to gel manicure, it's up to you Full Keren Hishtalmut, private health and dental insurance Volunteer days, donation matching, Yoga and Pilates A supportive, collaborative culture that puts our people first

Next Step:
Hit apply. You bring your compliance mindset; we’ll bring the challenge (and the snacks!)

We are looking for a Regulatory Affairs Specialist.
What you will be doing:
Provide regulatory support to the Development and Post marketing activities related to products.
Preparation and maintenance of regulatory submissions and registrations of products in relevant markets.
Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
Provide support for all external/internal audits at HQ and globally, as needed
Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
Attend other regulatory related needs, as required
Working according to Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.