We are always eager to meet motivated people who share our vision and wish to be part of our team.
To meet our clients’ expectations through the development, implementation, and delivery of their products we are currently looking to add to our team, the following:
QARA Professionals We offer to QARA professionals in the Medical Device industry a high profile and exciting job, learning how to operate as a consultant and widening and deepening your professional capabilities. Job Description: Establish, improve, and maintain QMS Systems, from design to manufacturing and distribution stages of the company. Lead vendor processes. Support CE and FDA certification processes. Prepare documents and design technical documentation in support of CE marking (MDR or IVDR), FDA submissions, or rest of the world based on the company strategies. Among your duties you may be requested to: ● Create Technical File/Documentation for all device classes and various geographies. ● Establish and/or maintain Quality Systems. ● Prepare & submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions. ● Lead Risk Management processes. ● Support design and development of products from a quality and / or regulatory perspective. ● Develop or support DMR, DHR, DHF ● Prepare annual planification’s for quality and regulatory activities (i.e. trainings, audits…) ● Advice on standards i.e. labeling UDI requirements. ● Lead or support special processes such as sterilization, cleaning, biocompatibility etc. –planning and managing the process to success. ● Participate in internal and external audits according to ISO13485, EU MDR, MDSAP. Desired experience and skills: ● Minimal 3 years working experience in various areas of Medical Devices ● Knowledge of the various stages of the product life cycle: design, clinical trials, manufacturing, and distribution phases ● Knowledge of Medical Device Quality and Regulatory requirements ● Ability to deliver results. Effective communication, collaboration, and flexibility to learn new work environments and relationships with customers. ● Technical or scientific degree (BSc, MSc or PhD) ● Fluent in English.
Lead Auditor and QA manager Job description: With the objective to help our customers to obtain, maintain or expand market access worldwide, we are looking for QARA professionals that are able and have experience with conducting and leading internal and external auditing i.e. FDA inspections, notified body audits according to ISO13485, EU MDR, MDSAP. The job will also require to prepare and support our customers with relevant Quality processes, implement QMS and regulatory documentation in support of CE marking (MDR or IVDR), FDA submissions including 510(k), PMA, Q-subs, or similar approval processes worldwide. Among your daily duties you may be requested to • Lead and manage processes such as sterilization validation, cleaning validation, biocompatibility etc. – both planning and managing the process to success • Lead and manage establishment of QMS • Participates and/or lead internal and external audits i.e. FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP. Job Requirements: • Minimal 5 years working experience in the field of Medical Devices including Systems, AI, SaMd, imaging, an advantage if you have working experience with processes such as sterilization validation, cleaning validation, biocompatibility etc. • Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) • Knowledge in Quality Assurance and Quality Engineering o Experience with Medical Devices in the following areas: DHF, Risk Management processes, DMR o IQ, OQ, PQ of various processes – production processes, clean room etc. o Knowledge and understanding in technical processes and risk evaluation • Ability to mentor, develop and engage staff, monitor performance standards and deliver results. Effective communication, good collaboration skills. • Technical or scientific degree (BSc, MSc or PhD) • Certified Lead Auditors • Fluent in English.
Clinical Writer We offer to Medical Writers a high profile and exciting job, learning how to operate as a consultant and widening and deepening their professional capabilities. Job Overview: As a Medical Writer specializing in medical devices at our consulting firm, you will be an essential member of our regulatory affairs team, working on diverse projects for various medical device companies. Your primary responsibility will involve creating and refining high-quality, accurate, and compliant clinical and regulatory documents that support our clients' medical device development, registration, and commercialization efforts. Your work will contribute significantly to ensuring regulatory approval and successful market access for our clients' medical devices. Key Responsibilities: • Clinical Document Preparation: Prepare, review, and edit clinical documents for medical device companies, such as clinical evaluation reports (CERs), periodic safety update reports (PSURs), clinical study reports … Ensure that these documents adhere to relevant regulatory guidelines and meet our clients' specific needs. • Project-Based Writing: Collaborate with cross-functional project teams to develop clinical documents tailored to each client's unique medical devices, therapeutic areas, and regulatory requirements. • Literature Research: Conduct thorough literature research to gather relevant clinical data and scientific information to support medical device regulatory submissions. • Data Analysis: Analyze and interpret clinical data and statistical reports to support the content of clinical documents and provide valuable insights to our clients. • Client Interaction: Engage in direct communication with clients to understand their specific requirements, address queries, and provide expert guidance on clinical writing matters. • Document Management: Maintain organized records of clinical documents, versions, and related files for each project, ensuring compliance with document management procedures. • Collaboration and Support: Collaborate closely with project managers, regulatory experts, and other team members to meet project timelines and deliverables effectively. • Continuous Improvement: Continuously assess and enhance our clinical writing processes, templates, and standard operating procedures to optimize efficiency and maintain the highest quality outputs. Qualifications and Skills: ● Education: Advanced degree in a Engineer or life sciences/clinical discipline • Experience: Previous experience in writing documents such as scientific articles, articles, clinical chapters for regulatory submissions… • Language: English at mother tongue level. • Scientific Literacy: Ability to critically analyze scientific literature, clinical data, and statistical reports to create accurate and customized clinical documents for each project. Familiarity with the use of online literature databases. • Writing Skills: Excellent writing skills, with the ability to adapt writing styles to suit different audiences and clients. • Attention to Detail: Meticulous attention to detail to ensure accuracy and compliance of clinical documents tailored to each client's requirements. • Collaboration: Strong team player with the ability to work collaboratively with cross-functional teams and build positive relationships with clients. • Time Management: Effective time management skills to prioritize tasks, handle multiple projects simultaneously, and meet project deadlines. • Ethics and Integrity: Demonstrated commitment to maintaining confidentiality, ethical writing practices, and adhering to regulatory requirements. • Flexibility: Ability to adapt to changing project requirements and client needs efficiently.
For additional information on posting above and to send your CV please mail to hr@hamada.co.il
