לוח משרות דרושים מנהל רגולציה

Manages and train Regulatory Affairs representatives and associated processes for preparation of product submissions, including 510(K), CE Technical Files (MDD and MDR), China, Canada, Japan, South Korea, and Australia and other International Countries.
Interact with Internal and External teams on regulatory related projects to meet regulatory compliance topics and regulatory tasks.
Lead the development and implementation of regulatory strategy for assigned projects of the relevant BU
Collaborate with Sr. Director Regulatory regarding EU, China, Japan, South Korea, Taiwan and other global territories regulatory teams for to implementation of develop global regulatory strategies for projects and submissions.
Approving labeling (including advertising and promotional materials) in the context of submissions or registrations and serving as the regulatory expert of the projects.
Provide regulatory advice and guidance to Regulatory Affairs representatives, engineering, and project teams to ensure submissions meet regulatory requirements and maintain up-to-date knowledge of regulatory requirements.
Manage, mentoring and train International Regulatory Associates/Leads for product submissions.
Will support and partner with Internal teams and functions in phases of design, development, production, and distribution of medical devices.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

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! Reporting to the Chief Operating Officer, the Director of Tech Ops, Israel will be a key member of the Israel Leadership Team. The Director will also be a member of the Global Tech Ops Leadership Team, contributing to global strategic discussions and initiatives. This role is responsible for setting the strategic direction and overseeing execution across Supply Chain, Quality Assurance, Regulatory Affairs, and Pharmacovigilance for both development programs and licensed products in the Israeli market. The Director will serve as a senior advisor to management on operational and compliance risks and will represent the company in interactions with regulatory authorities. This is a hybrid role that combines high-level strategic planning with hands-on operational leadership, supporting a growing pipeline and dynamic business environment.
Responsibilities:
Strategic & Functional Leadership:
* Lead the IL Tech Ops team across all operational domains
* Lead a large organization (~100 people), Including direct management of managers
* Define and execute strategy aligned with global and regional objectives
* Oversee planning, budgeting, and resource allocation
Quality & Regulatory:
* Ensure compliance with GMP, GDP, MPLO and global standards
* Lead the Quality Management system (QMS), including audits and management reviews
* Oversee regulatory submissions and lifecycle management
Supply Chain & Commercial Interface:
* Manage logistics, warehousing, and distribution operations
* Partner with Commercial and Finance on demand planning, launches, and inventory
* Ensure supplier qualification and contract compliance
Cross-Functional Collaboration:
* Act as a key liaison with regional leadership
* Align operations with business development and product lifecycle needs
* Drive global project execution
* Foster a culture of accountability, transparency, and continuous improvement
City:
Petah Tikva