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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 English
* 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 model: 3 days a week in the office – A must
* ₪1,000 net monthly wellness benefit – from therapy to Pilates to your kid’s art class
* Full Keren Hishtalmut, private health & dental insurance
* Donation matching, volunteering days, team outings, and mentorship programs
* A mission-driven culture that values ownership, trust, and meaningful impact

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

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

1. Be part of the company management team with responsibility to lead regulatory strategy planning for company products. 2. Responsible to prepare regulatory submissions across all products and platforms as needed. 3. Review and present to the management and CEO regulatory updates and status reports. 4. Responsible for the development and preparations of regulatory submissions across all products and platforms as needed. 5. Be the point of contact for all regulatory inputs and deliverables from headquarters for product and clinical research submissions. 6. Responsible for maintenance of product regulatory files and registrations (NoC, registration renewals, annual reports etc.). 7. Provide regulatory support to R&D - project regulatory requirements, assure adherence to the regulatory path and resolve emerging conflicts with regulatory requirements. 8. Responsible to provide regulatory support to manufacturing, logistics, engineering, supply chain and sales teams. 9. Responsible for regulatory assessment of customer complaints, reportability assessments and MDR’s to regulatory agencies. 10 . Act * as the person responsible for regulatory compliance (PRRC), responsible to ensure the following:
* The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
* All post market surveillance and reporting obligations are met, including reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions and analysis of vigilance data.
* For investigational devices projects , the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU medical device regulation (MDR) is issued. * This is a joint responsibility with VP of Global QA, where VP RA is the main responsible for the above activities

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

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:
In this role, you will
Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.
Perform coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Coordinate and implement MDR requirements related efforts in the organization.
Assess product changes and their global regulatory impact.
Lead or compile all materials required in submissions, 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.
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.
Coordinate project submission timelines in multiple regions.