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Quality Control Inspector
We are looking for a Quality Control Inspector to join our team!
Location: Netanya
BioProtect is an established Israeli startup in the medical device field, leading innovation in radiation protection. We develop and manufacture products suitable for a wide range of clinical applications in oncology and general surgery. The company’s flagship product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer.
What We Offer:
In this role, you will be part of the quality control process for products that improve patients' quality of life. Excellent conditions for suitable candidates include competitive salary, advanced training fund from day one, meal card, Highway 6 access, and more!
Responsibilities:
• Supporting the production line with documentation tasks.
• Checking the accuracy of production forms and identifying errors.
• Entering production data into the database.
• Responsibility for final product release.
BioProtect is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, 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.
Clinical Research Specialist
We are looking for a Clinical Research Specialist to join our team!
Location: Netanya, on site
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:
• Support the ongoing company clinical activities
• Support the execution of the Post Market Clinical Follow Up.
• Data management and analysis
• Support the company complaints process
A successful candidate will have the following qualifications:
• At least bachelor’s degree in biology, Biotechnology, or related fields
• A multitasker – can work with multiple deliverables, protocols and a wide range of people simultaneously Have sense of accountability / urgency with ability to set priorities
• Proactive attitude to solving problems / proposing solutions
• Ability to understand and analyze data
• High level English proficiency, speaking and writing
• Ability to work under pressure and in a multitasking way
• Excellent self – management and interpersonal skills
• Microsoft Office - Excel, PowerPoint
• Able to travel from time to time
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.
Clinical Research Manager
We are looking for a Clinical Research Manager to join our team!
Location: Netanya
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 Manager 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:
• Support Post-Market Clinical Follow-Up (PMCF):
Prepare and manage PMCF records, plans, and reports in alignment with regulatory requirements.
• Oversee Post-Market Surveillance (PMS):
Conduct data collection and analysis to ensure the safety and efficacy of our products.
Generate comprehensive PMS reports.
• Manage ongoing Clinical Trials:
Coordinate and oversee ongoing clinical studies, ensuring adherence to Good Clinical Practice (GCP) standards.
Work collaboratively with investigators and study sites to maintain timelines and quality standards.
• Perform Data Analysis and Management:
Collect, manage, and analyze clinical study data to draw actionable insights.
Provide detailed reports to stakeholders and regulatory bodies.
• Handle Complaints:
Manage complaints and adverse events reports in compliance with regulatory and company policies.
Ensure thorough documentation and follow-up on all reported issues.
A successful candidate will have the following qualifications:
• Master’s degree in life sciences, biomedical engineering, or else
• 3-5 Previous experience in clinical research with medical devices
• 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.
QA Validation & Product Lead
Location: Netanya
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 manage and oversee overall validation activities and ensure compliance with quality and regulatory requirements while supporting the organization’s goals.
This position reports directly to the QA/RA Director, reflecting its critical role in maintaining and enhancing quality standards.
In this position you will be asked to:
• Establish and review design V&V, excel files validation, and process validation protocols in accordance with standards and regulation requirements
• Evaluate processes and equipment to ensure regulatory and quality compliance.
• Review validation plans, test results, and summary reports for regulatory compliance
• Provide guidance on quality/regulatory requirements for validation activities, including production, manufacturing, user requirements specifications, and testing strategies.
• Offer cross-departmental support to ensure adherence to ISO13485, FDA requirements, and other applicable quality, validation guidance and regulations, including performing standards gap assessments.
• Understands validation/technical problems and evaluates their potential impact on product quality
• Evaluate potential impact of validations as part of change control process
• Provide quality assurance monitoring of projects to assure regulatory compliance of validation and design processes,
• Maintain the device risk management file
• Maintain Traceability matrices
• Participate in cross-functional teams to define validation strategies and objectives that support organizational needs.
• Participate in projects as a design team member to ensure proper selection of new equipment in support of validation.
A successful candidate will have the following qualifications:
• 4-7 years of experience within a medical device company
• Strong knowledge of medical device standards and background in qualification documentation review
• B.Sc. Engineer in Biomedical/Biotechnology – an advantage
• Experience in data analysis – an advantage
• Strong technical and engineering knowledge - – an advantage
• 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.
Engineering Project Manager
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 lead the engineering activities in the production line.
In this position you will be asked to:
• Lead engineering projects to support the production line.
• Manage the life cycle of production machines and jigs, including writing specifications, designing, testing, validating and line engineering.
• Manage and perform equipment and processes validation (IQ, OQ and PQ).
• Support the design and development of a scale up facility.
• Lead the installation and process definitions of tools
• Write documents for the production line, such as work instructions and production forms.
• Be hands-on in solving problems in production
• Troubleshoot issues related to the manufacturing equipment and the cleanroom environment.
• Work closely with Operation and Quality teams.
A successful candidate will have the following qualifications:
• B.Sc in Mechanical Engineering – must.
• Engineering background in multidisciplinary machine design and manufacturing.
• 5+ years of experience in medical device companies.
• Experience in production line technical support, proven experience in cleanrooms.
• Proven experience in process validations and qualification IQ/OQ/PQ.
• High technical writing abilities and experience in documentation.
• Proficiency in Solid works (and PDM)
• Excellent communication and interpersonal skills, include the ability to work independently as well as within a team.
• Fluent English and Hebrew (written and verbal).
5 Jobs