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Process Validation Engineer
We are looking for a Process Validation Engineer to join our team! Location: Tzur Yigal BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: In this job function, your primary role will be to support the process validation activities under the V&V team responsibility In this position you will be asked to: • Lead process validation (IQ/OQ/PQ) of equipment, systems, and processes; Write protocols and reports according to QMS and validation guidelines. • Work closely and in coordination with engineering, production, and QA teams. • Participate in design reviews of new or changed tooling, equipment, systems and processes. • Establish validation impact assessment as part of engineering change control process. • Follow up on the qualification testing execution in accordance with the protocols. • Conduct product testing activities under defined conditions to verify/reject product specification using scientific methods. • Support troubleshooting / investigating process validation related deviations. • Develop, assess, and formalize instructions and forms for production A successful candidate will have the following qualifications: • 3 years of experience in design control/process validation in a medical device company • B.Sc. Engineer in Biomedical/Biotechnology – an advantage • Experience in data analysis – an advantage • Strong background in qualification documentation review • Strong technical and engineering knowledge • Excellent written and verbal communication skills in both Hebrew and English • A team player with strong communication and collaboration skills BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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Clinical Research Specialist
We are looking for a Clinical Research Specialist to join our team! Location: Tzur Yigal BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: As a Clinical Research Specialist in BioProtect, you will be working with the clinical team, responsible for planning and execution of the company’s clinical targets. In this position you will be asked to: • Post Market Clinical Follow Up. • PMS and PMCF records, plans, and reports. • Support in planning and execution of plans for new product indications. • Clinical studies’ data analysis • Technical writing including abstracts and menu scripts A successful candidate will have the following qualifications: • Bachelor’s/Master’s degree in life sciences, biomedical engineering, or else • Previous experience in clinical research with medical device • GCP certified • Proficient in Excel • High – level English proficiency, speaking and writing • Ability to work under pressure and in a multitasking way • Excellent self – management and interpersonal skills Advantages: • Familiar with FDA regulations • CRA certification BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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Regulatory Affairs Specialist
We are looking for a Regulatory Affairs Specialist to join our team! Location: Tzur Yigal BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: In this role, you will be responsible for regulatory affairs activities including customer complaints handling, assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. In addition, assist in creation, and maintenance of regulatory files, assist in regulatory submission, annual reports, registrations, and listings. In this position you will be asked to: • Manage the overall customer complaints activities in the company, including: o Investigates & document customer complaints according to applicable regulatory requirements. o Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints. o Proactive collaboration with cross functional team members to get resolution on customer complaints. o Risk assessment of customer complaints o Compile and submit reportable events to relevant regulatory authorities in a timely manner. o Timely closure of customer complaints o Handle recalls and field actions, if required. • Maintain regulatory files. Maintain and update regulatory authorizations, such as 510(k)s, and CE dossiers for EU. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required. • Recognize potential regulatory issues from product development through the manufacturing process including review of ECOs for regulatory compliant, including management of registration, as applicable. • Management of annual reports and renewal of licenses to ensure compliance with local regulatory requirements. • Stay abreast of standards, regulatory procedures and changes in regulatory climate. • Authors new or revised site procedures as assigned. • Establishment and/or approval of documents require regulatory impact such as: Clinical Reports, Clinical Evaluation, PMS report, Essential Requirements, Product Risk Analysis etc. • Review product labels and promotional material for compliance with applicable regulations standards. • Participants in internal and external quality system audits and providing regulatory input. Assist in preparing response to regulatory authorities’ questions within assigned timelines. • Serve as a substitute Management Representative and PRRC
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Engineering Project Manager
We are looking for an Engineering Project Manager to join our team! Location: Tzur Yigal BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: In this role, you will build and design a new clean room facility and overall responsibility for its engineering activities. In this position you will be asked to: • Leading the design and development of a scale up facility (Clean room and production line) for a medical implant platform. • Lead all associated with tool-install and maintenance definitions including supportive machinery. • Qualify, document, and validate Facility, equipment, and processes for medical products manufacturing. • Work closely with operations and quality teams, vendors, and subcontractors • DFx methods, including design for manufacturing, testing, and cost optimization, addressing quality, schedule, and cost considerations. • Troubleshoot issues/interruptions related to manufacturing equipment and cleanroom environment.
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QA Lead
We are looking for a QA Lead to join our team! Location: Tzur Yigal BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. The opportunity: In this role, you will support manufacturing and operation with establishment and overall responsibility of Change Control processes. In this position you will be asked to: • Manage the overall activities of Change Control in the company, including: o Lead Change Control Committee in the evaluations of Change Proposals to assure appropriateness. o Provide training and mentorship to change initiators in assuring Change Proposals address requirements for change implementation. o Compile and analyze Change Control information required for Management Review, and other business needs, and prepare associated reports and/or presentation slides. o Determines need for Change Control Effectiveness Checks and Performs review/close out of Effectiveness Checks. o Performs review of Change Controls and final approval for implementation of changes. • Generate, implement and/or review completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. • Review and provide quality oversight of results of validation activities. • Review the results of testing and determining the acceptability of results against pre-determined criteria. • Investigate and troubleshoot problems and providing recommendations for changes and/or improvements. • Review, edit and approve deviation notifications, deviation investigations, corrective actions, change controls, SOPs, reports and other documentation. • Coordinate with other departments or outside contractors/vendors to complete validation tasks. • Assures compliance of local QMS procedure and updates as required. • Authors new or revised site procedures as assigned. BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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