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לפני 22 שעות
חברה חסויה
Location: Merkaz
Job Type: Full Time
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
Requirements:
BA or B.Sc. degree is required.
A degree in engineering, materials, chemical sciences is preferred.
5 years relevant/regulated industry experience
Demonstrated ability to communicate regulatory requirements clearly, accurately, and concisely
MDR knowledge and preferably experience in implementing it
Ability to confront new Regulation/ Guidance document
Experience with previous 510(k) submissions
Experience with previous technical file dossiers
Expertise in product development and its application in global regulatory strategy
This position is open to all candidates.
 
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לפני 20 שעות
דרושים בהרקלס גיוס השמה
Location: Ramat Hasharon
Job Type: Full Time
We are seeking a highly skilled Senior Project Manager to lead quality and regulatory projects in the medical device sector. The role involves delivering strong professional value to clients and managing projects across company offices, client sites, and remote settings.

Key Responsibilities
Manage quality and regulatory projects, ensuring alignment with scope, timelines, and budget.
Act as the main client interface, ensuring clear communication and high satisfaction.
Provide expert guidance on quality systems, regulatory requirements, and compliance standards.
Coordinate with cross-functional teams to deliver high-quality outcomes.
Promote continuous improvement and support operational excellence.
Requirements:
Bachelors degree in Engineering mandatory.
Minimum 10 years of experience in a medical device manufacturing company, with strong, proven references.
Demonstrated leadership experience in managing teams or complex projects.
Certified ISO 13485 Lead Auditor required.
Strong passion for the field, with motivation to excel and grow professionally.
Excellent verbal and written communication skills in English.
High customer-service orientation, strong interpersonal skills, and the ability to work effectively with multiple interfaces.
This position is open to all candidates.
 
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לפני 20 שעות
Location: Petah Tikva
Job Type: Full Time
Program Manager - CKD Therapy system Development
We are developing a next-generation therapy system for Chronic Kidney Disease (CKD), combining ultrasound imaging, precision control, and advanced therapy delivery. Were looking for a Program Manager to lead complex medical device programs from concept through clinical readiness, working at the intersection of engineering, clinical insight, and Product Strategy.
Key Responsibilities
Lead the program lifecycle from concept to clinical readiness
Manage cross-functional internal and external teams across software, ultrasound, control, and mechanical domains
Integrate complex subsystems into a cohesive therapy platform
Translate clinical needs into clear product and design requirements
Own execution: milestones, risks, budgets, and deliverables
Contribute to the technology and scale-up roadmap
Requirements:
5+ years of experience in medical device development and program management
Proven leadership of multidisciplinary teams
Strong technical understanding of ultrasound, control systems, and electromechanical design
Experience with design controls, V V, and regulatory processes
Excellent communication and stakeholder management skills
Experience working with subcontractors and consultants
Fluent English and willingness to travel
This position is open to all candidates.
 
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משרה בלעדית
לפני 35 דקות
דרושים באינישיה בע"מ
Location: Petah Tikva
Job Type: Full Time
We are seeking an experienced medical device sales professional to lead U.S. market entry and clinical adoption of a novel regenerative therapy system. The role combines commercial execution with building clinical partnerships and early market presence.
Key Responsibilities
Execute the U.S. commercial and promotional plan across regenerative medicine fields
Engage medical centers and KOLs for clinical trials and evaluation programs
Lead site agreements, ethics submissions, and trial launch coordination
Provide market and clinical insights to support commercialization
Requirements:
Bachelors degree in Biomedical Engineering, Life Sciences, or Business (advanced degree preferred).
5+ years of experience in medical device sales or clinical development, ideally within therapeutic medical devices.
Proven ability to negotiate and build relationships with physicians and institutions.
Strong communication, presentation, and organizational skills.
Willingness to travel frequently to/from the U.S.
This position is open to all candidates.
 
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חברה חסויה
Location: Migdal Haemek
Job Type: Full Time
We are seeking great talent to help us build The DNA of tech.
our company manufactures one of the world's largest portfolios of discrete semiconductors and passive electronic components, essential to innovative designs across the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. We help the world's most in-demand technologies come to life. Every day, our products touch your life and the lives of people across the world, though you likely do not know it. Join us and help us build the DNA of tech.
our company Intertechnology, Inc. is a Fortune 1,000 Company listed on the NYSE (VSH).
Do you want to help us build the DNA of tech.? our company Migdal HaEmek is currently seeking applicants for Process Engineer, In this position, the successful candidate will plan assigned operations or executes functionally focused in-depth analyses to ensure efficiency of services continuously or to provide relevant data, information, and/or service.
Job Location:
Migdal HaEmek - The position requires the ability to travel between sites located in Dimona and Beer Sheva.
Migdal Ha'Emek is located in the northern part of Israel.
The factory in Migdal Ha'emek was established in 1996 and has about 300 employees, most of whom produce capacitors that are embedded in various industries: Automotive, Telecom, Computers, Medical, Military, etc.
our company Migdal Ha'Emek provides its employees with support, a variety of tools for personal growth and a wide range of opportunities and advanced career within the company.
we are a stable and solid company which has served as home and family to thousands of its employees for many years.
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.
Requirements:
Bachelor's degree in materials engineering/physics/chemistry - mandatory.
Experience in an industrial plant in general and on a production floor in particular - a significant advantage.
High-level English - reading, writing, and speaking.
Good expression ability in writing and on paper.
Willingness for overtime.
High analytical ability - planning and analyzing data, conducting experiments.
Knowledge in MS Office.
Knowledge of ceramic materials and sintering processes - an advantage.
Knowledge of DOE experiment design and analysis - an advantage.
Knowledge of software: - JMP, MiniTab - an advantage.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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חברה חסויה
Location: Dimona
Job Type: Full Time
We are seeking great talent to help us build The DNA of tech.
our company manufactures one of the world's largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. We help the world's most in-demand technologies come to life. Every day our products touch your life and the lives of people across the world, though you likely do not know it. Come join us and help us build The DNA of tech.
our company Intertechnology, Inc. is a Fortune 1,000 Company listed on the NYSE (VSH)..
Do you want to help us build the DNA of tech.? our company Dimona is currently seeking applicants for a R&D Technician. In this position, you will be responsible for performing tests and analyses in a laboratory setting. They assist in the development of scientific techniques and procedures and maintain laboratory equipment and supplies.
Job Location:
Dimona is located in Southern Israel in the Negev, not far from the Dead Sea area, the lowest point on earth.
The factory in Dimona was established in 1986 and has over 1,000 employees.
our company Capacitors are embedded in various industries: Automotive, Telecom, Computers, Medical, Military, etc.
our company Dimona provides its employees with support, a variety of tools for personal growth and a wide range of opportunities for career advancement within the company.
we are a stable company which has served as a solid working environment and family to thousands of employees over the years.
What you will be doing:
Preparing chemical solutions, working in Chemical laboratory
Monitoring moving Engineering batches from station to station.
Conducting mechanical, physical, chemical, and electrical tests and measurements on products during the process.
Processing and analyzing results, creating graphs in Excel, and preparing presentations in PowerPoint.
Assist in the development and improvement of R&D procedures and techniques.
Maintain equipment in a proper working condition.
Ensure that R&D safety procedures are followed.
Document and report any deviations in procedures, equipment, or results to the appropriate personnel.
Keep up-to-date with industry advancements and update processes accordingly.
Requirements:
Degree in Chemical and Materials Engineering or a related field.
Proficiency in Microsoft Office is required.
Technical English proficiency is required.
Ability to perform chemical and electrical measurements and basic analysis of results.
Capability to handle complex tasks and meet deadlines.
Strong organizational skills, teamwork ability, excellent service orientation, and interpersonal skills.
Excellent analytical and problem-solving skills
Ability to work independently and as part of a team.
Strong attention to detail and accuracy of work.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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8503593
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חברה חסויה
Location: Be'er Sheva
Job Type: Full Time
We are seeking great talent to help us build The DNA of tech.
our company manufactures one of the world's largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. We help the world's most in-demand technologies come to life. Every day our products touch your life and the lives of people across the world, though you likely do not know it. Come join us and help us build The DNA of tech.
our company Intertechnology, Inc. is a Fortune 1,000 Company listed on the NYSE (VSH)..
Do you want to help us build the DNA of tech? our company Beer Sheva is currently seeking applicants for a Process Engineer. You will be responsible for designing, evaluating, and optimizing production processes to improve efficiency, reduce waste and cost, and ensure product quality.
Job Location:
Beer Sheva is the capital of the Negev, located in Southern Israel.
The factory in Beer Sheva was established in 1996 in the Emek Sarah industrial area and has over 1,000 employees. our company Resistors are embedded in various industries: Automotive, Telecom, Computers, Medical, Military, etc.
our company Beer Sheva provides its employees with support, a variety of tools for personal growth and a wide range of opportunities for career advancement within the company.
we are a stable company which has served as a solid working environment and family to thousands of employees over the years.
What you will be doing:
To develop and implement production processes in line with product specifications and quality standards.
To identify and analyze process issues and recommend improvements to increase efficiency and reduce waste.
To create and maintain production documentation, such as standard operating procedures and work instructions.
To collaborate with other departments, such as Manufacturing, Quality Assurance, and Research and Development, to ensure smooth production processes.
To monitor and evaluate production processes to identify opportunities for improvement and implement solutions.
To train and mentor production and maintenance teams on new processes and equipment.
Requirements:
Bachelor's degree in Machinery / Chemistry / Materials Engineering or related field
2+ years of experience in process engineering or related field
Strong analytical and problem-solving skills
Experience with process simulations and modeling software
Knowledge of industry regulations and standards
English - high level (speak, write)
Excellent communication and collaboration skills
Ability to work independently and as part of a team.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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8502321
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Location: Yokne`am
Job Type: Full Time
we are seeking a Senior Design Quality Assurance Engineer for our Urology division. This role involves developing, supporting, and managing risk for Medical Electrical Equipment/Systems (MEE/MES) and related accessories as part of New Product Development. Become part of a team shaping the future of the operating room, with a focus on advanced kidney stone treatments and innovative solutions for physicians and patients. Lead the development of safe, high-quality products and make a direct impact on patient care and clinical outcomes.

Your responsibilities include:

Lead product teams within the BSC Quality System to develop new MEE and MES as part of a core group of DQA Engineers supporting the Laser Therapies franchise. Special focus on:
Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
Utilize Systems Engineering practices to lead efforts for requirements management/system architecture to align risk mitigations with design inputs, design outputs at different levels (e.g., system / sub-system) for products that are both stand alone, and network connected.
Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
Lead Risk Management activities during all phases of Electrical HW/SW design, using design quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
Participate and lead in the creation and maintenance of Risk Management and Usability deliverables.
Lead and/or support development of NPD Reliability Engineering Program Plans and related reliability program activities.
May perform other duties as directed.
Requirements:
Minimum Qualifications

B.Sc in Biomedical, Electrical Engineering or equivalent.
5+ years of Medical device engineering experience, with experience in Medical Electrical Equipment/Systems (MEE / MES).
Experience with Reliability and Systems Engineering principles
Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971 and EN ISO 13485.
Strong leadership skills.
Hands on team player.
Coaches others in analysis and decision making. Strong communication and presentation skills.
Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and/or other electrical testing/simulation software.
Travel approximately 5-10%.
Preferred Qualifications

Certified Reliability Engineer and/or Systems Engineer
Experience with Software as a Medical Device (SaMD) and/or systems integration
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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06/01/2026
חברה חסויה
Location: Caesarea
Job Type: Full Time
we are looking for a Software Quality Engineer.
Main Responsibilities:
Manage, planning and execution of components level and E2E system tests with documented test results.
Participate in the verification and validation testing of the current and future products.
Ownership of designing, planning, and writing verification and validation testing documentation for existing and future products/features/modules, according to requirements.
Provide effort and time estimations of testing process for existing and future products/features/modules.
Lead the maintenance and definition of SW life-cycle related tasks including documentation and other regulation related issues.
Collaborate with Development, Applications, Project Management and Customer Support team members throughout the lifecycle of a project/product.
Assist other testing engineers with testing assignments and/or training.
Participate in customer and field issues support investigation.
Requirements:
Scientific or engineering degree in Computer Science/Bio Medical (or equivalent) from a well-known university/college
At least 5 years experience working as a SW testing engineer.
Experience with SW life-cycle procedures and documentation.
Keen interest in testing and quality issues.
MSc. in related field - an advantage.
Experience in bio-medical system testing - advantage.
Formal testing certification (ISTQB) - advantage.
Experience with manual testing - advantage.
Code/batch writing ability - advantage.
Technical ability in operating complex software and hardware- advantage.
Fast learner with can do approach.
Ability to work in a dynamic environment.
Excellent communication and interpersonal skills.
High-level self-learning and working independently.
English - Excellent written and oral skills a must.
Good analytic and problem-solving skills.
Excellent team player with the ability to work independently.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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8490344
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לפני 16 שעות
Location: Jerusalem
Job Type: Full Time and Hybrid work
we are seeking an Engineering Manager to lead the transition of its medical devices from R&D into scalable, compliant, and cost-effective production. This role owns the Design Transfer process, drives validation and qualification efforts, maintains the engineering and manufacturing BOMs, and provides hands-on support to production. The Engineering Manager will collaborate closely with Operations, Quality, and R&D to ensure manufacturability, robustness, and readiness for global scale.
The ideal candidate has deep hands-on engineering experience in medical devices, strong knowledge of manufacturing processes, and thrives in fast-paced, cross-functional environments.
Requirements:
Bachelors degree in Mechanical, Electrical, Biomedical Engineering, or related discipline.
5+ years of engineering experience in the medical device or regulated industry.
Hands-on experience with design transfer, NPI, or production engineering.
Strong familiarity with electro-mechanical manufacturing processes (PCBA, assembly, testing).
Experience with IQ/OQ/PQ and test method validation.
Strong BOM management and document control experience (ERP/PLM).
Knowledge of ISO 13485, 21 CFR 820, and ISO 14971.
Excellent problem-solving and data-driven decision-making skills.
Strong communication skills and ability to collaborate with R&D, Operations, Quality, and suppliers.
Familiarity with IEC 60601 or relevant electrical device standards (if applicable)
Nice-to-Have:
Experience working with contract manufacturers and global suppliers.
Experience in designing and validating jigs, fixtures, and test equipment.
Experience in cost-reduction initiatives and value engineering.
Previous leadership or mentoring experience of engineers/technicians.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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עדכון קורות החיים לפני שליחה
8506708
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תודה על שיתוף הפעולה
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לפני 20 שעות
Location: Tel Aviv-Yafo and Herzliya
Job Type: Full Time
We are seeking a talented and motivated Affera and Single Shot Therapy Account Consultant to join our team to further drive the growth of the business.
Reporting to the operating unit this role is critical in providing expert clinical and technical support and training to physicians and Electrophysiology Lab Staff on the optimal use of the Affera Mapping and Ablation System and the use of our single shot technologies (Cryo and PulseSelect).
Responsibilities may include the following and other duties may be assigned:
Provide proficient clinical and technical assistance to physicians and EP Lab Staff on the use of the Affera Mapping and Ablation System and related equipment (Generators, SW functionalities, pump and accessories). Both Single shot technologies - Cryo and PulseSelect.
Provide in-service training to introduce new technologies to various hospital stakeholders and ensure technology acceptance.
Play an active role in the planning and effective installation of the Affera Mapping and Ablation System and efficiently collaborate with the technical department.
Share clinical best practices with colleagues to continuously optimize customer experience.
Work with field service engineers on technical troubleshooting.
Support sales processes in dedicated accounts .
Participate in regional and occasionally international congresses, symposia and workshops.
Requirements:
Bachelor's degree required in bio- medical engineering or practical engineering, electrical or related scientific disciplines.
Ability to manage high-stress situations with a clear problem-solving mindset.
Must have a valid drivers license.
Fluent English skills.
Availability and willingness to travel.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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עדכון קורות החיים לפני שליחה
8506197
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