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Jobs found: 32 result(s)

Head of Quality/Regulatory

MainzGermany€120,000 - €170,000
Head of Quality and Regulatory Affairs Are you passionate about Quality Management and Regulatory Affairs? Are you a hands-on leader, with expertise in managing RAQM processes in the diagnostics field? Are you looking for a role where you can have the freedom to really drive change and make a difference for your team? Apply now to join my client, a leading international diagnostics company, as their new Head of Quality and Regulatory Affairs! Ready to put your skills to work? Your Tasks: Maintain QMS and ensure compliance with applicable quality & regulatory requirements Provide leadership, guidance, and mentoring to Quality and Regulatory teams Identify and implement initiatives to enhance the quality system and drive efficiencies Timely resolution of non-conformances and complaints Budget & Stakeholder Management incl. communication with Notified Bodies Your profile:   Master or higher degree in science or a related field Min. 10 years’ experience in quality assurance and control, preferably in the medical device or diagnostic industry. Extensive knowledge of ISO13485, FDA 21 CFR 820, IVDR/MDR Demonstrated ability to drive change, implement best practices, and achieve results. Fluent German and English Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 16639819 #LI-VU1  
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Employee for Production Control and Planning

FreiburgGermanyFlexible, depending on experience
Employee Production Control and Planning   Overview Do you have experience working in Production Control and Planning? Are you looking for a new challenge in the medical device industry? Are you looking for a great company culture that is open-minded, innovative and very future-oriented? Our client near Freiburg who specializes in medical endoscopes is looking for an employee in production control and planning to join their team. Tasks Production and progress control of internal and external delivery including dates and quantity as well as ensure on-time deliveries to customers Coordination of development and sample orders and identify bottlenecks Contact person between departments and other divisions  Analysis of value steams, identification of potentials and implementation of suitable measures   Your profile Completed a commercial or technical vocational training or training in the logistics sector Experience in scheduling or work preparation and knowledge of MS Office High awareness in quality and ability to work under pressure Strong communication and organizational skills Fluency in German and English Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management. +49 30 1663 7750 #LI-MC2  
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Software Engineer

InnsbruckAustria€50,000 - €65,000 DOE
Are you searching for your next career step in Software Engineering? Would you like to join an innovative team in the medical device field who are known for their high-tech advancements in the microscopy field? We're currently supporting a client who are headquartered in Innsbruck and are looking to strengthen their team. Responsibilities: Develop and implement software solutions tailored for medical devices, with an emphasis on robotics and imaging technologies. Work closely with the R&D team to create cohesive and integrated solutions. Engage in architectural design and the development process, fostering innovation and improving product performance. Operate within a development environment that adheres to industry standards and regulatory requirements specific to medical technology. Perform code reviews and maintain software to ensure the highest quality standards are met.   Requirements and Skills: Bachelor's degree in Computer Science, Software Engineering, or similar. Proficiency in programming languages such as C++ and Python. Experience working with the Linux operating system. Familiarity with tools like Confluence, Jira, Git, and Continuous Integration (CI). Fluency in English, German is a bonus.   If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information. #LI-HB1  #LI-Hybrid  
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Risk Manager

MunichGermany65,000EUR - 75,000EUR
Are you interested in joining a dynamic company who are innovating in the cardiovascular field? Would you like to have a major impact on the successful market delivery of medical devices and transform treatment options for patients? We're currently supporting a client in the medical device industry who are headquartered in Munich and are looking to strengthen their team. Responsibilities: Initiate, maintain, and update the risk management process in compliance with ISO 14971, 21 CFR820, and other relevant standards. Develop, maintain, and update all documents within the risk management file, including risk management plans, FMEAs, annual reports, and more. Coordinate and oversee all risk management activities with cross-functional teams.. Contribute to the assessment of customer feedback and risk evaluation, analysing quality issues, complaints, incidents, and proposed changes related to known and potential new risks. Prepare all risk-related documents for the technical file, such as risk-benefit analyses. Support and plan product Design Verification and Validation activities. Requirements and Skills: Bachelor’s degree in Engineering or a related field. 3+ years of experience in risk management of medical devices in accordance with ISO 14971, ideally for class II or III devices. Proficiency in technical, regulatory, and medical writing, with experience in drafting technical reports.  Fluency in English, German is a bonus. Experience working with regulatory bodies and competent authorities. Basic understanding of regulatory requirements for medical devices, particularly MDR and 21 CFR820. If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information. #LI-HB1  #LI-Hybrid  
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HR Manager

DevonUnited KingdomFlexible, depending on experience
HR Manager Devon, United Kingdom Are you experienced in HR management and seeking for next career step? Our client, a leading medical device manufacturer located in Devon, is seeking a HR Manager to join their team. In this role, you would oversee HR operations across Europe and the UK, ensuring seamless functionality of all human resources functions. From managing recruitment processes to fostering positive employee relations and ensuring legal compliance, you'll play a key role in driving organizational success. Tasks: Managing all aspects of onboarding and offboarding processes for both permanent and temporary staff. Overseeing the recruitment process and collaborating with external HR consultancy to ensure all policies, procedures, forms, and handbooks are up-to-date. Providing regular advice to managers on employee relations matters, staffing issues, and compliance with legal developments. Participating in formal employee relations meetings, including probation reviews, and overseeing disciplinary, grievance, attendance, and capability cases to resolution. Handling employee requests for information and managing absence. Overseeing performance reviews and HR document management. Working closely with payroll to record changes accurately and resolve any queries. Development of the benefits packages, leading employee events and maintaining staff noticeboards. Performing any other tasks as directed by senior management. What is required: Previous HR management experience. Strong relationship-building skills with proactive and self-motivated approach. Maintaining professionalism and confidentiality. Being approachable and patient with capacity to multitask. CIPD Qualification preferred. Fluency in English and knowledge of French language is required. Are you ready to advance your HR career? Take the next step in your development by applying now and joining a team dedicated to fostering a supportive and inclusive workplace environment! If you have any questions regarding the position, please contact: Dominika Wyrwinska at #LI-DW1 #LI-Hybrid  
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Quality Control Manager

LeipzigGermany€60,000 - €65,000 DOE
Quality Control Manager  Are you passionate about maintaining the highest standards of quality in medical device manufacturing and eager for the next step in your career? Our client, based in Saxony, is currently seeking a Quality Control Manager to join their team. Specializing in regenerative medicine and cutting-edge technology, our client excels in developing innovative products. As their Quality Control Manager, you will play a vital role in ensuring their innovative products meet quality standards.   Responsibilities: Establish quality procedures, standards, and specifications. Collaborate with purchasing manager to ensure raw materials meet quality requirements. Assess company production processes to develop in-house quality policies and procedures. Ensure compliance with local and global production standards. Implement and monitor quality assurance standards. Oversee product-related projects with subcontractors and internal departments and monitor product development processes.  Handle post-process activities such as sterilization, packaging, and shipment. Requirements: Bachelor of Science or similar education with minimum of 2 years of experience. Technical training or studies, ideally in quality or measurement. Analytical thinking and independent working style. Proficient in Q methods and tools, Microsoft 365 (especially Excel). High commitment and willingness to learn. Fluent in German and English with strong communication skills. If this sounds like you, please do not hesitate and send the application. If you have any questions regarding the position, please contact:  Dominika Wyrwinska at #LI-DW1 #LI-Hybrid  
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Account Manager North Germany

RemoteUnited Statesopen to discuss
Our client is a global respiratory diagnostics leader and is currently looking for an  Account Manager RDx Germany in Berlin.  Experience: Technical and / or commercial  sales Experience in complex structures within the hospital environment Safe dealings with customers Ability to move customers to action Strong sales performance Strong sales  mindset Willingness to travel incl. overnight stays Knowledge:        Sales negotiations and deals with buyers in a hospital, doctors, as well as other decision-makers. Knowledge of Medical Devices Low Germany Safe handling of MS Office applications Word,Excel, PowerPoint and Outlook. Knowledge of spoken and written English. Goals of the job: Achievement of the specified sales targets in the assigned sales area. Strong focus on numbers an goals Team player in a Vyaire structure Improve patient outcomes and provide greater value for our customers Maintaining and expanding Vyaire's market position. Take care of existing customers Acquisition of new customers Work to be carried out (main tasks): Consulting and sale of Vyaire lung function (PFT) and ergospirometry (CPET) products. Sales negotiations and deals with purchasers, general practitioners and other decision-makers. Planning and execution of trial orders Participation in trade fairs Independent planning of trips, if necessary also with overnight stays Reporting of business-relevant numbers - regular forecast – Maintaining “Salesforce” Maintaining and Evaluating a Project List Market and competition monitoring Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic +4915123483158  Mobile #LI-SH2 #LI-Hybrid
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Embedded Software Engineer

FreiburgGermanyFlexible, depending on experience
Are you an experienced Embedded Software Developer, and open for your next career step? Would you like to have an impact on the development of high quality medical devices? Join an innovative medical technology company, who are known globally for their advancements in the endoscopic field. Responsibilities:   Develop embedded software for medical endoscopes, focusing on image processing. Analysis of existing systems to identify optimization opportunities in both software and hardware design. Take charge of software design, architecture, and implementation. Generate specifications and testing strategies for software, ensuring thorough documentation. Translate system requirements into precise software specifications. Collaborate with circuit and FPGA design developers to implement hardware-related application and operating system components (utilizing Linux/Yocto on FPGA). Develop and integrate SoC-specific Board Support Package (BSP) into embedded Linux OS builds. Experience required: Degree in Computer Engineering, Electrical Engineering or comparable. Demonstrated experience in system software development, particularly with Linux/Yocto on FPGA/C/C++ or similar embedded systems. Fundamental grasp of software design and development methodologies. Preferably you will bring experience in a regulated industry (ideally medical technology). Ideally you have familiarity with Xilinx Zynq UltraScale+ MPSoc and its development environment. Fluent German and English is required. If you're interested in this position, please apply here and/or contact Hollie Dear. #LI-HB1  #LI-Hybrid  
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