לוח משרות דרושים רישום / רגולציה רפואית

Lead and manage clinical regulatory submissions, including IDE submissions, IRB/EC applications, amendments, and ongoing study maintenance.
Serve as the regulatory lead for US and EU clinical investigation activities, supporting first?in?human, feasibility, and pivotal studies.
Prepare, review, and maintain clinical regulatory documentation, including protocols, Investigators Brochures, clinical risk sections, and regulatory responses.
Support regulatory strategy development for clinical programs, ensuring alignment with development, clinical, and business objectives.
Act as a primary regulatory interface with FDA and European regulatory bodies related to clinical studies.
Collaborate closely with Clinical, R D, Quality, Biostatistics, Operations, and external clinical partners/CROs.
Participate in cross?functional discussions supporting new product development and clinical evidence

we are looking for a Senior Regulatory Affairs Specialist Medical device.
The Senior RA specialistwill be responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices. Responsibilities include planning and executing regulatory submissions for the US, EU, and other international markets, creating and maintaining technical files, managing complaints, overseeing change activities, and ensuring post market compliance. The role collaborates with cross functional teams - including QA, R&D, Clinical, Manufacturing, Operations, Marketing, and Commercial - to ensure compliant efficient, and timely market access throughout the product lifecycle, including sustained compliance.
Responsibilities:
Market Expansion & Global Regulatory Registrations:
Prepare and maintain global regulatory submissions (e.g., India, Australia, Singapore, Mexico) and author full submission packages. (e.g., EU MDR Annex II/III TD, US 510(k), ANVISA, SFDA, NMPA).
Monitor regulatory changes and ensure sustained compliance across all markets, including labeling, UDI, and post-market updates.
Conduct jurisdiction -specific impact assessment for product changes and manage global propagation of design, labeling and UDI updates.
Collaborate with R&D, Operations, Marketing, and product teams throughout new product development and commercialization to ensure regulatory alignment
Review technical documentation and ensure compliance across the full product lifecycle
Serve as the QA/RA point of contact for cross-functional programs and regulatory-related initiatives.
Maintain existing registrations, manage renewals and variations, and oversee global portfolio compliance.
Develop and execute global regulatory strategies for new market entry (US 510(k), EU MDR, Canada MDL, LATAM, APAC, MEA), including interpret country-specific requirements, identification of testing and labeling needs, and creation of submission roadmaps.
Lead pre-submission meetings and manage interactions with health authorities and notified bodies.
Ensure compliance with ISO 13485, 21 CFR 820, EU MDR, and applicable country regulations.

Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.

The role will be Hybrid and require visits to the sponsor office weekly.

Sponsor requirements are:
Strong local experience and knowledge in Israeli regulations and submissions.
Beside the role being a lead role, it requires a lot of local regulatory knowledge.
Fluency in Arabic.


Essential Functions

Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents.

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Home Based role requiring experience with both submissions and contract negotiations within Israel as well as fluency in Hebrew.
Essential Functions
Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

we are transforming the delivery industry by making drone delivery a real-world, scalable solution. We are looking for a Regulatory Affairs Lead to join the company regulation team and play a key role in major regulatory and compliance efforts that support the certification of advanced UAS platforms and the execution of groundbreaking operational projects. You will be part of a fast-growing company, working with a highly multidisciplinary team in a dynamic environment in the heart of Tel Aviv. In this role, you will support and lead regulatory activities related to the certification, approval, and operation of our companys UAS platforms. Working at the intersection of regulation, operations, engineering, and business, you will interpret complex regulatory frameworks, help shape compliance strategies, and support engagements with aviation authorities and other relevant bodies. You will collaborate closely with cross-functional teams to translate regulatory requirements into practical internal guidance, documentation, and processes that support safe, compliant, and scalable real-world operations. Main Responsibilities
* Review, interpret, and monitor aviation regulations, standards, and policy developments relevant to the companys activities.
* Support and lead regulatory approval efforts with aviation authorities and other relevant organizations.
* Assess the impact of regulatory requirements on company operations, products, and processes, and recommend appropriate actions.
* Prepare, review, and manage regulatory documentation, including manuals, position papers, internal guidance materials, filings, presentations, and compliance records.
* Collaborate with cross-functional teams, including product, engineering, operations, and management, to develop and implement processes and procedures that support regulatory compliance across the organization.
* Prepare and submit regulatory filings, applications, permits, and other documentation required by regulatory agencies, ensuring accuracy, consistency, and adherence to deadlines.
* Track industry trends, evolving standards, and emerging regulatory issues in order to identify compliance risks and support proactive mitigation strategies.

we are seeking a senior leader to own global governance, regulatory oversight and compliance. we are seeking a senior leader to own global governance, regulatory oversight, and compliance, operating in a CCO capacity and working closely with leadership, regulators, auditors, and financial institutions.
Regulatory Titles: AML Compliance Officer, Complaints Officer, Deputy Money Laundering Reporting Officer
Works closely with regulators, financial institutions, and internal leadership. Cross-functional coordination with Legal, Finance, Investor Relations and Operations. Supervision over Compliance and Governance managers, and global compliance officers.
we are headquartered in Jerusalem and has an office in Tel Aviv. This is a hybrid role, requiring 3 days in office.
Title and seniority will be determined based on the candidates experience.
Responsibilities
GOVERNANCE
Own global governance across our company entities (e.g., structure, ownership, board processes, action resolutions), including lifecycle (setup, maintenance, wind-down)
Coordinate top board-level action resolutions, charters and committees with Corporate Secretary
Govern authorizations, corporate records and reporting around directors/officers, beneficial owners and signatories
Oversee KYC data rooms, institutional requests, and audit readiness
REGULATORY
Own licensing, exemptions, and regulatory reporting across multiple jurisdictions (e.g., US, Canada, Australia, Hong Kong, Singapore, Cayman Islands, BVI, etc.)
Lead regulatory audits, inspections, and ongoing jurisdictional compliance
Act as internal expert on cross-border regulatory strategy and distribution
COMPLIANCE
Own our companys global compliance program (e.g., AML/KYC, sanctions, onboarding, policies, training)
Supervise global compliance officers and resources (internal + external)
Sign off on key filings and regulatory submissions
Oversee compliance calendar and compliance monitoring program
Handle complex investor onboarding, transfers and accreditation matters
Participate in senior cross-functional operations and risk management meetings.

The Senior RA specialistwill be responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices. Responsibilities include planning and executing regulatory submissions for the US, EU, and other international markets, creating and maintaining technical files, managing complaints, overseeing change activities, and ensuring post market compliance. The role collaborates with cross functional teams - including QA, R&D, Clinical, Manufacturing, Operations, Marketing, and Commercial - to ensure compliant efficient, and timely market access throughout the product lifecycle, including sustained compliance.
Responsibilities:
Market Expansion & Global Regulatory Registrations
Prepare and maintain global regulatory submissions (e.g., India, Australia, Singapore, Mexico) and author full submission packages. (e.g., EU MDR Annex II/III TD, US 510(k), ANVISA, SFDA, NMPA).
Monitor regulatory changes and ensure sustained compliance across all markets, including labeling, UDI, and post-market updates.
Conduct jurisdiction -specific impact assessment for product changes and manage global propagation of design, labeling and UDI updates.
Collaborate with R&D, Operations, Marketing, and product teams throughout new product development and commercialization to ensure regulatory alignment
Review technical documentation and ensure compliance across the full product lifecycle
Serve as the QA/RA point of contact for cross-functional programs and regulatory-related initiatives.
Maintain existing registrations, manage renewals and variations, and oversee global portfolio compliance.
Develop and execute global regulatory strategies for new market entry (US 510(k), EU MDR, Canada MDL, LATAM, APAC, MEA), including interpret country-specific requirements, identification of testing and labeling needs, and creation of submission roadmaps.
Lead pre-submission meetings and manage interactions with health authorities and notified bodies.
Ensure compliance with ISO 13485, 21 CFR 820, EU MDR, and applicable country regulations.
Post-Market Activities
Develop, implement and maintain processes to ensure compliance with applicable regulatory standards and requirements
Maintain documentation and quality records in compliance with ISO 13485, QMSR,
and internal QMS (e.g., change management, technical file updates)
Support internal audits, management reviews, and quality improvement initiatives
Participate in risk management activities and lead or support CAPA investigations, nonconformances and root cause analysis
Serve as the companys Complaint Designated Unit (CDU), managing the full lifecycle of medical devices complaints, including trend analysis, investigations, and reporting to authorities.
Participate in external audits and inspection readiness activities
Conduct regulatory gap assessments and execute remediation plans (CER updates, PMS/PMCF plans, ISO 14971 risk management).
Drive closure of regulatory-related CAPAs and support audit and inspection readiness.
Manage post-market surveillance deliverables (e.g., PSUR, vigilance reporting) and ensure timely corrective actions.
Other
Follow all company policies and procedures (safety, compliance etc)
Attend all required company training
Demonstrate commitments to our company Behaviors by leading, acting, and modeling these values.

What youll do
As Manager, Regulatory Compliance, Israel you will deliver on the regulatory engagement strategy for our company in Israel. You will maintain our licensing responsibilities and coordinate with all internal and external parties as necessary to ensure compliance through the communication of regulatory requirements, cross-functional collaboration to productize solutions and offerings, implementation and execution of processes, filing of all requisite reports, renewal of registrations and licenses, end-to-end management of regulatory examinations, and interfacing with our regulators on ad-hoc inquiries. You will analyse new and existing products and provide guidance to ensure that our 2LOD controls are fit for purpose and comply with regulatory obligations and guide the first line business to enable the maturity of both customer-facing and internal back-office processes and product features.
Responsibilities:
Support the company Groups expansion by managing the regulatory compliance components of licence authorisation processes
Act as a key stakeholder in relation to licence applications, business plan updates and information requests between our company and our regulators
Ensure that our regulatory compliance and integrity risk reporting obligations are maintained in the region
Support and / or manage on-site exams and inspections (in collaboration with our LRC colleagues)
Advise the business with respect to regulatory change initiatives with a particular focus on how to effectively manage compliance risk attached to new laws and regulations in the jurisdictions we operate
Develop policies, processes and provide advice in relation to regulatory risk obligations that exist within the 1st line business
Manage regulatory compliance risk within the company Risk Management Framework and associated escalation process (inc. the Group Risk Committee)
Advise the business in relation to conduct risk and ethics matters (where appropriate) relating to our financial services licences
Deliver the Compliance Monitoring Program; Conduct targeted and thematic reviews on a wide range of topics to ensure appropriate organisational maturity
Deliver the company Groups Compliance Training for employees and conduct ad-hoc training to specific business areas as required
Conduct Proactive Special Ops projects to unlock business or operational issues to enable our company to achieve its strategic goals more rapidly.

DRS RADA is a global pioneer of radar systems for active military protection, counter-drone applications, critical infrastructure protection, and border surveillance. We are looking for an experienced Global Manufacturing Program Manager to join our team. This role involves managing complex programs from planning through full implementation, including knowledge transfer, production infrastructure setup, and compliance with regulatory and logistical requirements.
* Lead complex programs for establishing manufacturing and maintenance sites abroad, from planning to full execution
* Drive knowledge transfer processes to international teams
* Establish and implement production lines, processes, and operational procedures
* Collaborate with cross-functional teams, including Engineering, Operations, Procurement, Logistics, and international stakeholders
* Manage local and international suppliers and subcontractors
* Ensure compliance with quality standards, regulatory requirements, and security protocols
* Oversee project timelines, budgets, and risk management