לוח משרות דרושים רישום / רגולציה רפואית, לחיפוש זה נמצאו 27 משרות

Medison 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 30 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 want to make a difference in people's lives, we invite you to join us! The Regulatory Affairs Appointed Pharmacist will supports all Regulatory Affairs activities, including but not limited to preparation of registration dossiers, ensuring compliance with regulatory requirements, drafting product documentation, developing patient leaflets, overseeing packaging design, and managing updates to product labeling.

Responsibilities:

* Provide professional regulatory advice to Medison’s business units and partners.
* Planning and executing regulatory activities, periodic updates of approved dossiers and managing the change control process for pharmaceutical products.
* Good relationships with regulatory authorities and Medison’s partners and advancing timelines in the registration processes.
* Preparing registration dossiers, including content verification according to SOPs, submission, and tracking of registration dossiers with the Ministry of Health.
* Preparing packaging materials, including review and submission in accordance with the Ministry of Health requirements and in compliance with the product's registration
* conditions.
* Handling all types of submissions, new products, changes, and renewals.
* Ensuring that publications intended for the medical staff comply with Ministry of Health requirements and adhere to the product's registration conditions.
* Preparing registration dossiers for medical devices, including submitting registration applications, renewing licenses according to SOPs, and supporting the company's
* medical equipment and devices unit with registration requirements.

City:
Petah Tikva

we are looking for a highly skilled and motivated Senior Academic Editor to lead and support the preparation, writing, and submission of peer-reviewed scientific publications related to our clinical, technological, and regulatory activities.
This is a cross-functional role that requires excellent academic writing skills in English, strong collaboration across departments (Clinical, R&D, Product, Regulatory), and the ability to communicate complex scientific data in a clear and compelling way.
The ideal candidate has a background in life sciences, biomedical engineering, or clinical research, and a proven track record in academic publishing-preferably in the fields of medical devices, SaMD, AI in healthcare, or digital health.
Responsibilities:
Write, edit, and manage scientific manuscripts, abstracts, posters, and white papers for submission to peer-reviewed journals and scientific conferences.
Collaborate with internal teams (Clinical, R&D, Data Science, Regulatory) to gather and validate data for publication.
Conduct literature reviews and maintain up-to-date knowledge of relevant clinical and scientific developments.
Manage the end-to-end publication process, including journal selection, formatting, submission, and peer-review response.
Support clinical and regulatory documentation when relevant, such as clinical evaluations, study reports, or white papers
Maintain a pipeline of upcoming publications and coordinate timelines with key stakeholders.
Ensure all scientific materials align with strategic positioning and messaging.

We are seeking a proactive and detail-oriented AI Regulatory Engineer to ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements-particularly FDA regulations for AI-enabled medical devices.
This role is critical as AI has become a highly regulated domain, requiring specialized regulatory strategies, risk management approaches, and lifecycle governance. The AI Regulatory Engineer will work closely with AI engineering, clinical, quality, product management, and regulatory affairs teams to define and execute the correct AI regulatory and submission strategy across the full product lifecycle.
Job Description
Key Responsibilities:
AI Regulatory Strategy & Compliance:
Interpret and apply regulatory frameworks and guidance for AI-enabled medical devices, including FDA, EU MDR/IVDR, and global regulations.
Define and drive AI regulatory strategies for clinical ultrasound features, including SaMD and AI-enabled device functions.
Design and execute clinical validation strategy and plans for AI-driven ultrasound products in compliance with regulatory standards.
Support FDA submission pathways (e.g., 510(k), De Novo, PMA) for AI-based features, including AI-specific regulatory positioning.
Risk Management & Safety for AI:
Lead AI-focused risk management activities in accordance with ISO 14971, addressing AI-specific hazards such as bias, robustness, generalization risk, and clinical misuse.
Perform and maintain AI-specific risk analyses (e.g., AI FMEA, algorithm hazard analysis, clinical performance risk).
Ensure traceability between clinical requirements, AI behavior, risk controls, and verification/validation evidence.
Regulatory Documentation & Submissions:
Prepare and maintain AI-related regulatory documentation, including:
AI descriptions and intended use statements
Training and validation dataset descriptions
Performance evaluation and clinical evidence summaries
Algorithm change management and lifecycle documentation
Support creation of FDA-ready AI documentation, including transparency, explainability, and human-factors considerations.
AI Lifecycle & Change Management:
Define regulatory-compliant AI lifecycle strategies, including updates, retraining, and change impact assessment.
Support implementation of Predetermined Change Control Plans (PCCP) or equivalent AI lifecycle strategies.
Ensure alignment between AI development practices and regulatory expectations for locked vs. adaptive algorithms.
Cross-Functional Collaboration
Collaborate closely with:
AI engineers and data scientists
Clinical and medical affairs teams
Quality, systems, and V&V engineers
Product management and regulatory affairs
Embed regulatory and safety requirements early into AI design, data strategy, and clinical validation plans.
Regulatory Intelligence & Audits:
Monitor evolving AI regulations, FDA guidance, standards, and industry best practices.
Communicate regulatory changes and their impact on AI roadmaps and product strategy.
Support internal audits, design reviews, and external regulatory inspections related to AI and clinical safety.
Provide training and guidance on AI regulatory and safety topics to engineering and product teams.

Flytrex is transforming the delivery industry by making drone delivery a real-world, scalable solution. We are looking for a Regulatory Affairs Lead to join the Flytrex 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 Flytrex’s 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 company’s 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.

Support labelling (i.e. operator manuals, handbooks etc.) documentation update and overall process Support ongoing regulatory compliance activities such as complaint handling, submission of reportable events to authorities (vigilance), sales tracking and approval, and MRB. Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules. Provide support for audits in HQ and globally, as needed Perform other duties as deemed necessary

Exciting opportunity to be part of Imaging Informatics regulatory team. Imaging Informatics
business unit includes solutions for radiology and cardiology. From enterprise imaging, PACS, and
workflow orchestration, through to a full suite of solutions for the cardiovascular workflow, we deliver
optimized imaging service lines that enable enterprise imaging across sites, specialties and technologies
to simplify medical image management, enable effective collaboration and enhance patient care. This role
will focus on radiology regulatory activities.


Responsibilities:
Represent regulatory affairs at the Radiology Informatics leadership team
Through end-to-end regulatory processes, ensuring safe and effective products are brought to
market, on time, and sustained throughout life cycle via compliant, innovative regulatory
strategies
Manage day-to-day functioning of radiology regulatory team ensuring effective and efficient
execution
Provide critical input on regulatory risk assessments to support portfolio selection and post
market decision making
Build proactive, strategic relationships with external stakeholders (Notified Bodies, FDA,
Competent Authorities, etc.) to ensure that requirements are known early during strategy
development, which enables fast market access with the current portfolio in connection with
future innovations.
Lead and enable strong cross-functional partnership between regulatory affairs and all key
stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at
all levels within the business, and the local Regulatory Affairs teams in the market
organization.
Mentor and develop regulatory talent and competency to ensure strategic engagement and
execution excellence

Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, Alma has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Alma’s headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide. Key Responsibilities A. Risk Management – Mandatory / Top Priority
* Perform and maintain risk management activities according to ISO 14971 across the full product lifecycle.
* Develop, update, and maintain Risk Management Files (RMF), including:
* Perform FMEA (all types)
* Hazard identification
* Risk analysis and risk evaluation
* Risk control measures and mitigation strategies
* Residual risk assessment
* Benefit–risk analysis
* Lead and actively participate in risk analysis activities and meetings (e.g. FMEA, FTA, Hazard Analysis).
* Ensure technical risks specific to energy-based systems are properly identified, documented, and controlled, including (HW, SW, Clinical etc.):
* Verify, document, and maintain evidence of risk control effectiveness.
* Integrate design data, design/engineering changes, service feedback, complaints, and post?market information into ongoing risk evaluations.
* Provide risk-related input for:
* New design project
* Design changes and product modifications
* CAPAs
* Product improvements
* Regulatory submissions and updates
* AE – Adverse Events
* PMS activities B. Regulatory, PMS & Adverse Event Responsibilities (Core Responsibility)
* Perform post?market surveillance (PMS) activities in accordance with global regulatory requirements, including data collection, analysis, and documentation.
* Conduct adverse event (AE) and complaint assessments, including:
* Initial assessment and classification
* Support and execution of investigations
* Risk evaluation and impact assessment on product safety and performance
* Reporting to regulatory authorities
* Ensure integration of AE, complaint, service, and PMS data into risk management files, maintaining continuous risk evaluation.
* Perform trend analysis of complaints, adverse events, and post?market data to identify safety signals, emerging risks, or systemic issues.
* Prepare and maintain PMS documentation, including contribution to and preparation of PSURs, with clear linkage to risk management outputs.
* Participate in and support regulatory assessments and submissions.
* Ensure all PMS, AE, and risk-related documentation is accurate, traceable, and audit?ready.
* Participate in internal and external audits related to risk management, vigilance, and PMS activities.

Subsidiary:
Alma LTD

we are looking for a Medical Data Analyst to join our growing Implementation group, reporting to our Squad Lead. The ideal candidate will be responsible for ensuring the successful implementation of new clients and analyzing both historical and real-time client data.



As a Medical Data Analyst, you will:

Analyze and understand clients business objectives, coding patterns and methodologies in order to configure Clinical language understanding engine for optimal performance.
Support clients throughout the technical integration and engine onboarding processes, documenting solutions and proactively improving client-specific outcomes through hands-on work with our codebase to adjust configurations, scripts, and rules.
Actively troubleshoot, investigate, and resolve coding discrepancies, distinguishing issues arising from client-specific configurations versus core engine functionality.
Provide solutions for alerts and incoming escalated tickets from our customers.
Collaborate across multidisciplinary teams - including engineers, linguists, medical doctors, product managers, customer success managers and coders -to ensure smooth project execution and effective communication.

Alma, a Sisram Medical company, is a global leader in medical-aesthetic technologies, with over 25 years of experience in energy-based devices (EBD). Over the years, Alma has evolved into an integrated aesthetic and wellness ecosystem that combines medical devices, injectables, diagnostics, and personalized skincare. The company operates in a dynamic, innovation-driven environment, merging advanced technology with deep clinical understanding to create holistic solutions for aesthetic clinics. Alma’s headquarters are in Caesarea, Israel, with business operations in more than 100 countries worldwide. · Prepare, compile, submit, and maintain global regulatory submissions. · Support regulatory activities across the product lifecycle, including new product introductions, design changes, software releases, labeling updates, and change control processes. · Perform regulatory impact assessments for product changes and ensure timely updates to technical documentation and risk management files. · Maintain regulatory records, technical documentation, declarations, and evidence of conformity per applicable regulations and standards. · Review and approve labeling, IFUs, UDI and promotional materials to ensure compliance. · Provide regulatory guidance to R&D, Quality, Operations, Marketing, and Clinical teams; · Participate in audits/inspections and interface with regulatory bodies/certification bodies as needed.

Subsidiary:
Alma LTD