לוח משרות דרושים רישום / רגולציה רפואית, לחיפוש זה נמצאו 22 משרות

Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation
The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

What You'll Do:
Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
Act as a key-contact at country level for all submission-related activities.
Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.
Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieve companys target cycle times for site activations.
Prepare the regulatory compliance review packages, as applicable.
Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
Develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
Oversee country study files and ensure that that they meet PPD WPDs or client SOPs.
Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate
Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate.

As a Country Approval Specialist, you will participate in the management and preparation, review and coordination of Country Submissions in line with global submission strategy in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Supporting the facilitation of site start up and communication with internal and external team mem-

bers to ensure prompt site approval and study timelines are achieved.

Support sites and study teams to achieve rapid site start up

Essential Functions:
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Key-contact at country level for either Ethical or Regulatory submission-related activities.
Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
Achieves PPDs target cycle times for site.
May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
May develop country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Required Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting
The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. We offer a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
The Patient Centered Solutions team (PCS)
The PCS team leads the industry in the science of measuring the patient experience. We pair strategic consulting expertise with technical scientific knowledge to design and execute scientifically rigorous research that incorporates the patient voice into the development and commercialization of new medicines. This research includes qualitative (e.g., patient interviews, focus groups), quantitative (e.g., clinical outcome assessments (COAs)/patient-reported outcomes (PROs), preference research) and passive (e.g., digital health technology tools) approaches to understand patient, caregiver and physician experiences and expectations of disease and treatment.
Why join?
Become part of a recognized global leader in patient-focused research
Keep growing with an organization that encourages and invests in continuous professional and personal development
Apply your business and leadership skills in an entrepreneurial and multi-disciplinary team
Continue challenging yourself by addressing the toughest client issues, working across multiple geographies and solutions in a dynamic and crucial field for the industry
Make a difference to patients by enabling the successful approval or launch of new treatments with features that are truly patient-centric
Responsibilities:
The Associate Principal/ Principal Clinical Outcome Assessment (COA) Endpoint Strategy serves as the subject matter expert for COA endpoint strategy, endpoint development, COA regulatory strategy, and COA instrument science in client engagement and project delivery. This role brings deep expertise in COA measurement science to differentiate client solutions through expert-driven, highly insightful endpoint strategies. The role acts as a trusted advisor to pharmaceutical and biotechnology sponsors and represents us as an external scientific thought leader while ensuring internal scientific quality and best practices.
Key responsibilities include:
Client Strategy Leadership & Scientific Differentiation:
Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects.
Bring COA expertise into client meetings, workshops, and strategic discussions.
Differentiate proposals and client solutions through expert-driven COA strategy narratives.
Translate emerging scientific and regulatory expectations into actionable client recommendations.

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.

The Director of Quality is responsible for leading Quality Management System execution for digital therapeutics and Software as a Medical Device (SaMD) products. This critical leadership role ensures our products meet the highest standards of safety, efficacy, and compliance across the entire product lifecycle. You will play a key role in shaping and maintaining the QMS, establishing and driving operational excellence, and supporting regulatory submissions, with a focus on continuous improvement and cross-functional collaboration.

Work Environment
This role is based in our office in Ramat Gan, offering the opportunity to collaborate closely with our dynamic team in person.

Responsibilities
Serve as the primary owner of Quality Management System (QMS) for SaMD, ensuring compliance across the product lifecycle and acting as the main point of contact for all quality-related matters.
Serving as the internal lead for Document Control and Employee QMS Training, and maintaining procedures and records; support future transition to eQMS, including validation when required.
Collaborate cross-functionally with Product Management, Engineering, Project Management, and Clinical teams to write and compile technical documentation and Design History Files (DHFs) for regulatory submissions.
Ensure regulatory compliance and provide oversight by implementing and maintaining adherence to GMP, FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366, and other applicable global and local standards. Translate regulatory requirements into efficient internal processes.
Manage post-market surveillance activities such as customer complaint handling, nonconformance investigations, CAPA processes, and regulatory reporting.
Maintain audit and inspection readiness, and lead or support inspections by regulatory agencies (FDA), notified bodies, partners, or other stakeholders.
Provide leadership in risk management by guiding cross-functional teams in creating and maintaining risk management documentation, including hazard analyses, design/user risk assessments, cybersecurity risk assessments, risk management plans and reports, and risk control implementation.
Lead continuous improvement initiatives to enhance the QMSs effectiveness and efficiency, including defining and tracking KPIs, identifying trends, and delivering actionable insights to leadership.
Oversee supplier management processes, ensuring supplier qualification, validation, and continuous monitoring of software suppliers and service providers to maintain regulatory compliance.
Contribute to the preparation and review of regulatory documentation, ensuring submission content is clear, consistent, and aligned with relevant standards and expectations.
Promote a culture of quality throughout the organization by delivering employee training programs and fostering quality awareness and ownership across all teams.

We are looking for an Associate Director, Medical Affairs position to be responsible for the medical affairs team in Israel, responsible for Oncology. The Associate Medical Director is a non-promotional role which leads a team of Medical Affairs Manager/MSLs who engage in scientific exchange with healthcare professionals and scientists (HCPs), with emphasis on regional and national scientific leaders and key decision makers.

The Associate Medical Director is responsible for the teams scientific activities and performance. Although the Medical Advisor is the owner of the strategic plan, the Associate Medical Director may also provide input and insight based on his/her team interaction with their SLs and other stakeholders engagements into the Medical Affairs strategy and ensure that it translates into concrete engagement (action) plans in the field.

The Associate Medical Director may also represent us in a range of local, national and international non-promotional Medical Affairs activities.





The job duties include the following:

Budget Planning and Resource Management.
Hires, manages, coaches and develops a group of Medical Affairs Managers/MSLs assigned to his/her therapeutic areas to ensure the highest quality scientific exchange in alignment with the Medical Affairs plan.
Provides input into the therapeutic area Medical strategy led by the local Medical Affairs Managers.
Ensures that there is adequate and compliant cross-functional collaboration between the Medical Affairs Managers/MSLs and internal stakeholders.
Organizes regular team meetings for relevant trainings, sharing of best practices, reinforcing on compliance matters and discuss therapeutic area strategies.
Develop his/her Medical affairs managers/MSLs functional and scientific skills.
Establishes the annual performance objectives for his/her team.
Conducts mid-year and year-end reviews of team performance.
Develops and maintains up-to date scientific knowledge around relevant disease areas, products within those areas and research methodologies.
Ensure optimal scientific leader management and support
Develop medical strategy (including the Medical Affairs plan, MAPs)
Align medical strategy with business unit/franchise-needs with marketing
Responsible for the creation and timely execution of all Medical activities in his areas of responsibility including medical education, data generation activities etc...
Responsible for close follow ups on all systems updates of the activities under his responsibility.
Review and approve s MSL plans.
Collaborate with GCTO and Market access around new products.
Ensures that all Medical Affairs Managers/MSLs perform their duties in alignment with company SOPs/Guidelines and local laws and regulations.