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

This role is based in Tel Aviv, Israel. our company is unable to offer relocation support for this role. Please only apply if this location is accessible for you.

Imagine leading the regulatory strategy for one of the world's most innovative healthcare companies while helping bring transformative medicines to patients across Israel. As Regulatory Affairs Head, Israel, you will shape the country's regulatory vision, influence healthcare policy, build trusted relationships with Health Authorities, and lead a high-performing team driving patient access, portfolio growth, compliance excellence, and business success. This is a unique opportunity to operate at the intersection of science, strategy, leadership, and innovation, making a meaningful impact on patients, the healthcare system, and the future of our company in Israel.
About the Role
Key Responsibilities
Lead country-wide regulatory strategy across development, registration and lifecycle management to maximise portfolio value.
Drive timely regulatory approvals and patient access while ensuring continuity of supply.
Provide strategic regulatory guidance to business leaders, anticipating risks, opportunities and changing requirements.
Build, develop and inspire a high-performing Regulatory Affairs team and future talent pipeline.
Establish and maintain influential relationships with Health Authorities and key external stakeholders.
Champion compliance excellence, inspection readiness and data integrity across regulatory activities.
Contribute regulatory leadership to country, regional and global initiatives, shaping future healthcare access.

We are seeking a detail-oriented Product Environmental Compliance Specialist to ensure our company's adherenceto applicable environmental, materials and product compliance regulations. The ideal candidate will have a strong understanding of environmental compliance requirements and the ability to interpret, implement, and monitor regulatory obligations throughout the product lifecycle.
How your job will look like?
Stay up to date with evolving global regulatory requirements and industry standards, ensuring compliance across all relevant areas.
Manage and maintain compliance systems and tools (e.g., Silicon Expert, Agile, and similar platforms), ensuring accurate regulatory data, reporting, and support for compliance processes.
Monitor and interpret changes in environmental and product compliance regulations and standards (e.g., RoHS, REACH, ELV), assess their impact, and coordinate implementation of required actions.
Collaborate with product, engineering and development groups to conduct thorough risk-assessments, identify potential compliance risks and develop effective mitigation strategies.
Develop and maintain compliance policies and procedures, to ensure requirements are integrated into product design and development processes.
Obtain, review, and maintain required compliance documentation, certifications, and regulatory declarations.
Train staff in compliance with requirements and best practices.

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.

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.