דרושים » ביוטכנולוגיה » Regulatory Affairs Specialist

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities
Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Ensure timely license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Monitor and document post marketing activities, analysis of trends, vigilance processes.
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes.

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.

We are seeking a Project Manager with a strong chemistry or technical regulatory background to support the operational, analytical, and cross‑functional activities of the Regulatory Affairs team.
In this role, the Project Manager will lead the planning, coordination, and execution of regulatory and cross‑departmental initiatives, ensuring alignment with organizational priorities and timelines. The position requires strong project management expertise and excellent communication skills. Responsibilities include coordinating team workflows, preparing project documentation and presentations, and facilitating effective collaboration with internal stakeholders, external partners, and regulatory service providers.

Key Responsibilities:

Lead material compliance projects, including planning and execution.
Develop, maintain, and monitor project plans, timelines, milestones, and deliverables.
Track team progress, ensure follow‑up on open items, and help remove obstacles.
Assist in annual and ongoing budget planning and management.
Coordinate and collaborate with R&D, Operations, Engineering, Legal, and other teams across the organization.
Monitor, interact, report, and provide support to local R&D and Engineering regarding compliance matters, enforcement actions, remedial activities, and regulatory requirements.
Manage global initiatives, ensuring alignment and effective utilization of cross‑functional resources.
Work with advisory services and manage regulatory subcontractors.
Assess local and regional compliance requirements and implement programs/systems to ensure regulatory compliance.
Gather strategic intelligence on evolving product regulations, advise management, and drive implementation of required compliance actions.
Generate or collect necessary documentation to support certifications and coordinate submissions to certifying laboratories/organizations.
Evaluate regulatory trends and revisions, and work with functional departments to proactively adjust processes to avoid certification disruptions.
Develop workflows, protocols, and tactical direction to support standardization and administration of product compliance programs.
Ensure all stakeholders are aligned and informed of progress, changes, and dependencies.
Prepare clear, professional presentations and reports for internal and external audiences.

Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
Key Responsibilities:
Daily duties include supporting the project team (R&D, SQA, Product, System and so on) during the development of a project. Our engineers review each design input and output deliverable throughout the development process and resolve compliance impediments as they arise. As a senior engineer the candidate will be responsible for defining two major evolving components in our work:
Implementing AI in our processes - What are the regulatory requirements for implementing AI in a medical device and how to implement it in our development lifecycle.
Cybersecurity work instructions in compliance with the new FDA guidance, train the various teams on the guidance and its implications to our process, and establish best practices for supporting post market vigilance.

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 25 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 are looking to make a difference in people's lives, we invite you to join us! We are hiring a Temporary Regulatory Affairs Coordinator who will support the activities of the RA team, including but not limited to handling documents, placing orders with suppliers, managing packaging and office supply inventory, and performing general office tasks. The role also includes fulfilling additional assignments as requested by the direct manager.

Responsibilities:

* Preparing registration portfolios (new, renewal, and update) for submission to the MOH, and updating tracking charts for each product.
* Coordinating deliveries to the MOH and managing fee payments.
* Preparing packaging graphics in collaboration with the registration pharmacist, graphic designer, and manufacturer.
* Preparing user manuals for submission in accordance with MOH regulations, and coordinating review and approval with printing presses and manufacturers.
* Sending documents for translation and coordinating with translators and manufacturers; performing translation and proofreading in English.
* Ordering packaging materials and office supplies.
* Monitoring the validity of approvals for new and existing customers.
* Preparing regulatory submissions (new, renewal, and update) for the MOH.
* Preparing packaging artworks in collaboration with the registration pharmacist, graphic designer, and manufacturer.
* Preparing leaflets and artworks for submission in accordance with MOH regulations and coordinating further approvals with manufacturers.
* Tracking and updating RA activities in the SharePoint system and internal tracking tables.
* Printing letters and various pharmaceutical-related requests.
* Performing additional tasks as requested by the direct manager.


City:
Petah Tikva

The Senior Product Quality and Reliability Engineer will provide leadership and management for the Networking system product quality within the organization. Establish, maintain, and optimize an effective quality management methods and target to achieve high quality performance.

As part of our team , you will work on networking system products and ensure their readiness for high-volume manufacturing. Leading and mentoring root cause analysis for issues related to design, manufacturing or customers. Enhance and improve products performance by proactive risk assessment and other prevention methods. This is an outstanding opportunity to be part of a company that is crafting the future of AI and computing.

What youll be doing:

Own Product Quality and Reliability performance of Networking system products. Providing leadership expertise in product performance and quality.

Maintain and monitor product health thru structured routines and metrics, enable effective alert mechanism for early identification.

Lead structured problem solving and risk assessment for quality issues originating from production and customer. Ensure product readiness for HVM manufacturing and scale.

Responsible for customer quality issues and working within organization to resolve.

Lead critical processes for product performance e.g - CRB, PCN ; Non conforming material review - MRB.

Drive continues improvement initiatives in design, verification and validation processes, manufacturing quality throughout the entire product life cycle and improvement plan.

As part of our team , you will work on networking system products and ensure their readiness for high-volume manufacturing. Leading and mentoring root cause analysis for issues related to design, manufacturing or customers. Enhance and improve products performance by proactive risk assessment and other prevention methods. This is an outstanding opportunity to be part of a company that is crafting the future of AI and computing.

What youll be doing:

Own Product Quality and Reliability performance of Networking system products. Providing leadership expertise in product performance and quality.

Maintain and monitor product health thru structured routines and metrics, enable effective alert mechanism for early identification.

Lead structured problem solving and risk assessment for quality issues originating from production and customer. Ensure product readiness for HVM manufacturing and scale.

Responsible for customer quality issues and working within organization to resolve.

Lead critical processes for product performance e.g - CRB, PCN ; Non conforming material review - MRB.

Drive continues improvement initiatives in design, verification and validation processes, manufacturing quality throughout the entire product life cycle and improvement plan.

Do you want to help us build the DNA of tech?
we are currently seeking applicants for Process Engineer.
In this position, the successful candidate will plan assigned operations or conduct functionally focused, in-depth analyses to ensure the continuous efficiency of services or to provide relevant data, information, and/or services.
What you will be doing:
Willingness to travel between sites located in Dimona and Beer Sheva
To operate within the production area, developing, implementing and managing manufacturing methods, processes and sequence of operations.
To define process requirements, working procedures, and provide equipment recommendations for product lines.
To execute Process-FMEA analyses, identifying possible sources of failures and taking measures to eliminate operational risks.
To define the process control methodologies and manage statistical process control systems to analyze out-of-control situations.
To liaise with Quality Assurance in responding to customer inquiries, and with Design Engineers to coordinate the launch of new products.
To monitor functional-specific trends and derive recommendations for their (incremental) improvements.
To execute focused research, create informative reports to support change or adaptation for processes and infrastructure systems.
To contribute to projects or processes to improve functional efficiency and effectiveness.
To take over the accomplishment of dedicated (local or function-specific) workstream, as part of an overarching infrastructure project.

The Sr NPI Engineer will be responsible to represent the Operation and lead new projects and transfer them to production including the following:
E2E OPS rep for all New Products Introduction cross functional, following our company PLCM.
Responsible for building Product/Production file, Product documentation, BOM, jigs/tools/Fixtures design
Manage TK vendors and Critical vendors
Responsible for moving from prototype to mass production, including PL establishment and manufacturing strategy
Responsible of full Design transfer process during the PLC stages.
Full cooperation under Program and Project managers guidance
In this role, you will
Responsible for leading the transfer of a new product from development to production. Leading and implementing NPI processes for a multidisciplinary product.
Create Product Portfolios and write Testing requirements.
ECOs Leading and Process/Mold Validation Protocols leading End to End ( write, execute)
Supply solutions to production failures.
Construct and maintain complex Bills of Materials (BOM).

The Senior Product Quality Manager will provide leadership and management for the product quality passionate about Customer issues. Establish, maintain, and optimize an effective quality management method and benchmark to achieve high quality performance. Serve as knowledge expert of product quality, leading and mentoring in identifying fundamental causes behind issues originating from manufacturing and customer blocking issues. Enhance and improve products performance by proactive risk assessment and other prevention methods.

What youll be doing:

Responsible for HW Product Quality performance at customer install base of Networking Switch products.

Lead structured problem solving and risk assessment for quality issues arising from production and customer.

Maintain and supervise product health through structured routines and meaningful metrics, enabling an effective alert mechanism for early identification.

Responsible for customer quality issues and working within organization to resolve.

Passionate about improving processes to reduce client grievances and in-house waste with a strong dedication to quality.

Maintain and improve product build improvements, verification and validation processes, manufacturing quality to allow high quality of Networking System products throughout the entire product life cycle and improvement plan.

Drive for Quality process improvement initiatives to minimize customer complaints and internal scrap, drive internal quality approach.