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Regulatory Affairs Specialist Our client based in North Rhine-Westphalia is currently looking for a Regulatory Affairs Specialist to support their team taking part in product introduction, post-market surveillance, and putting the technical documentation together. You would work for a global leader in offering sustainability to maintain a safe and clean environment by offering various hygiene, water, and infection solutions and services. Your tasks: Preparation of documentation and processes independently related to MDD, MDR, PMS, Vigilance, regulatory intelligence, and regulatory watch. Ensure accuracy in running platforms like Sharepoints, Complaints handling, EPIC, or others by taking the lead in this area. Finish challenging tasks requiring in-depth regulatory expertise, such as MDR, MDCG guideline implementation, change control, and handling compliance issues; additionally, represent the RA department in project team meetings. Active involvement in PMS, including the vigilance process, and product introduction. Attend project team meetings and represent the RA department. Respond to inquiries from both internal and external clients. Collection of technical documents in accordance with EU MDR 2017/745 on Medical Devices Give direction and supervision to various teams working on medical device regulatory watch and regulatory intelligence. Lead the Regulatory function during Notified Body audits. What is required:   Bachelor’s degree in a technical field with previous experience working in Regulatory Affairs. Effective problem-solving skills and ability to work independently. Good knowledge of macros in Excel and Word, MDD, MDCG guidelines, and ISO 1345 (ideally parts of audits, PMS, and vigilance). Excellence in office tools. Fluency in German and English.  Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology. Dominika.Wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid  

Regulatory Affairs Specialist Overview My client is a global leader in the design, manufacture, and distribution of cutting-edge mobility devices and solutions. Operating in 18 countries and with products available in over 130 countries, they specialize in manual and power wheelchairs, pediatric mobility devices, daily living aids, and more. Tasks Implementation of quality system components focused on regulatory compliance with MDR 2017/745, ISO 13485 and ISO 14971 Managing projects and activities for the improvement of products and processes from a regulatory standpoint Monitor and ensure the compliance of regulatory requirements (Europe, Switzerland & UK) Management of CAPA system, tracking of recalls and FSCA Participate in risk assessment activities such as uFMEA Collaborate with the Quality Director Europe to ensure documentation is compliant Assist in liability claim investigation and document collection Your profile 2+ years professional experience in regulatory affairs or quality management relating to medical devices Thorough knowledge of regulatory requirements (e.g. MDR, ISO 13485 & ISO 14971) Computer proficiency with MS Office Strong communication skills, good organizational skills, analytical thinking and a high level of reliability Fluency in English and German is a bonus 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. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

We are HR Partners of Vyaire Medical. Vyaire Medical is a unified breathing company that focuses on improving the lives of those treated with our devices.  We are a recognized leader in the Respiratory Diagnostics, Ventilation, and Anesthesia Delivery & Patient Monitoring market segments.  Vyaire Medical is also the largest pure-play company of its kind. We empower our people to challenge the status quo while pioneering innovation; in order to continually provide solutions that restore and maintain patients’ vitality and independence, while also increasing our value to our clients. ABOUT THIS ROLE This role will be responsible for Demand Forecasting control, Procurement, Inventory management of Imported and self-manufactured Finished goods distributed and shipped through International Supply Chain team, with a view to ensuring timely availability of inventory to satisfy customer demand within company specified performance parameters   In particular you can expect to: Procurement/Buyer PO creation, manually or System generated purchase requisitions and Place approved PO with supplier and acknowledgement. Keep ERP data up-to-date Manage Intercompany STO’s , increase working capital and reduce non-working capital. Understand lead-time from suppliers to enable timely delivery of finished goods to meet customer demands. ASN creation and make sure the goods are delivered and booked in time to meet customer demand Ensure all records are created and maintained in appropriate files. Keep ERP data Up-to-date. Enter purchase orders and requisitions information into ERP system and raise purchase orders on suppliers Manage all procurement activity based on forecast using tools and systems available and within company procedures and work instructions with a view to consistently and timely identification of purchase requirements Review all system generated recommendations to ensure consistency with inventory and Demand requirements Develop supplier relation to understand any supply constrain and work to improve the situation Work closely with support departments such as sourcing to elevate and resolve issues in the supply chain caused by supplier performance or availability Monitor excess and obsolete inventory and develop strategies/plans to eliminate excess Identify and drive cost savings opportunities to eliminate high expenses drive from the way product is planned and moved from supplier to DC/Customers Manage EOL (End of life) and NPI (New Product Implementation) processes Customer Development and Measurement Liaise with Customer service, Sales & Marketing, Finance to drive lowering the cost of supply, enhancing supply chain responsiveness, adoption of new technologies and entrepreneurial purchasing strategies Develop relationships with internal customers, Sales & Marketing, such that knowledge of alternative material is available at all times Participate in business to business conference calls and meetings to facilitate excellence in supply chain processes Ensure timely planning information is made available to key stakeholders and customers to satisfy reporting requirements Ensure effective and current documentation of all planning systems and processes are maintained Reporting Report to manager about project status, variations in delivery timeline or quality and advise the manager of corrective actions to be taken The employee will immediately report all potential risks, operational failures, time constraint problems and extraordinary events that will negatively impact the project to manager You will have the opportunity to: Improve patient outcomes Meaningfully impact the company’s short-term and long-term success Work closely with executives across the organization Grow your role as you see fit Learn everything there is to know about respiratory medical device manufacturing Create an inspiring workplace To be successful, you will need: Experience of working within a fast paced supply chain environment, over multiple sites. Strong analytical skills. Excellent  written  and  verbal  communication  skills Knowledge ERP systems, specifically: SAP 6.0 ECC - MM/SD modules Advanced level of MS Office, specifically Excel Pursues work proactively with drive and suggests ways to improve processes to fulfill the department’s need. Good spoken and written English with the ability to effectively communicate complex business issues to people at all levels within the organization. Adapts to varying work situations and is flexible in the approach to resolving challenges. Proven project Management experience. Demonstrates a solid knowledge of programs, processes, reporting systems, relevant software applications, analytical techniques/tools, compensation concepts, and current regulatory guidelines.   Some logistics: Location : Vyaire International Headquarters, Basingstoke UK  with required overseas travel time to time One of our unique strengths is the diversity of our community. We want to treat each associate fairly and provide equal employment opportunities regardless of a person’s race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic. Sanela Hasanovic Snr Specialist, HR Operations sanela@adaptivelifescience.com +4915123483158  Mobile #LI-SH2  

                                                    Quality Manager Central Europe On-site role North Baden-Wurttemberg base If you have a solid experience working in a manufacturing environment, and a leadership role – I might have the perfect opportunity for you! Our client – a World leader specialising in manufacturing & distribution of advanced assistive mobility devices & solutions is currently looking for a Quality Manager to ensure products & the site meet the requirements as set in the current regulations. About the role: Site Quality Management, including managing of the team as well as the processes. Work closely with the Directors of RA & Quality Management on complaints and failure investigations to determine root cause & permanent corrective actions. Facilitating and assisting in the analysis of field failures and in process production failures to improve the product and processes. Promote and foster a culture of continuous improvement, to include manufacturing & design processes & documentation across the board. Ensure compliance of the product risk management documentation according to ISO 14971. Support procurement team in the development and maintenance of supplier quality, to include maintenance of processes. About you: Master or Bachelor Degree in Engineering with several years of handson experience in Quality management or similar in a manufacturing environment. Extensive experience in implementing continuous improvement in a lean manufacturing environment. Experience managing/ supervising quality technicians and engineers. Excellent organizational ability, including ability to manage deliverables and timelines for execution to achieve project goals. Ability & willingness to travel domestically & internationally as required. Excellent written and verbal communication skills in both English & German languages. If you are interested in finding out more about this or other vacancies within Med-Tech, please contact Kasia Krasuska on: Kasia.Krasuska@Adaptivelifescience.com +49 30 16 63 83 76 #LI-KK2  

Full Stack Web Developer Are you a Full Stack Developer, interested in working for a MedTech company that specializes in cardiotherapy? Our client located in Bavaria is currently looking for a Full Stack Web Developer to join their established team and support them in expanding their current database. Your tasks: Extend their current operational data annotation framework Identify opportunities to expand and improve the database Support the team to ensure the company can provide emergency services through data-supported product development Work with Python backend, database (PostgreSQL), TypeScript frontend (ReactJS, and data pipelines What is required: Previous experience working in software development, especially web development in the front and back end Experience in Databases (SQL) and Python Good knowledge of software engineering methods such as design patterns and test-driven development Interests in learning Kubernetes Fluency in English and German What is offered: Hybrid flexibility Travel Allowance In-house gym Work events Sports groups  Please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in Medical Technology. Dominika.Wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid  

                                                    eQMS System Manager On-site role North Baden-Wurttemberg base Join world’s leader specialising in manufacturing & distribution of advanced assistive mobility devices & solutions. Our client is currently looking for an experienced eQMS System Manager to manage implementation, optimisation & continuous improvement of the eQMS across the board. About the role: Lifecycle management of the Quality Management software, to include installations & configuration, and development of new workflows for testing and validation. Training of users & local System Administrators, as well as managing access and rights for users. Collaborating closely with the software provider to resolve issues as they arise, update or implement additional functionality within the system. Development of reports based on needs of end users and the management, to enable efficient real time reporting. Working closely with RA & Quality to ensure compliance with current standards and regulations. About you: Master or Bachelor Degree in Engineering with several years of experience with system administration. Previous Master Control experience in MedTech or a similar field is desired. Familiarity with HTML language would be an advantage. Understanding of industry requirements and trends toward preserving data integrity, including FDA Guidance for Industry on “Data Integrity and Compliance with cGMP.” Project Management experience & skills, as well as strong problem solving abilities. Great communication skills and attention to detail. If you are interested in finding out more about this or other vacancies within Med-Tech, please contact Kasia Krasuska on: Kasia.Krasuska@Adaptivelifescience.com +49 30 16 63 83 76 #LI-KK2  

Senior Software Developer (C++/Linux) Are you a seasoned Embedded Software Developer thinking about your next challenge? Does the MedTech world excite you, and would you like to be part of an established team who are developing cutting-edge medical devices in the cardiotherapy field? Consider applying for our client’s new opportunity to join their team and support with: Focuses: Creation and integration of high-quality software components for life-saving medical devices Working with customized embedded Linux Further development and optimisation of software components Communication and collaboration with the wider team, including international colleagues Experience required: A degree in the field of computer engineering/software development Strong experience working with C++ Strong experience with Linux (or MacOS) Good knowledge of Git, CMake and Docker Fluency in English (German is desirable) If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com #LI-HB1  #LI-Hybrid  

Senior Software Developer (C/QNX) Our client in the MedTech space are searching for an experienced Software Developer who knows their way around real-time embedded systems. Does this sounds like you, and would you be interested in working together on the development of life-saving medical devices? You’ll enjoy exciting tasks such as: Focuses: Independent creation of software architecture and design principles for real-time operating systems Agile product development (SCRUMBut) Independent software safety-critical implementation with documentation Development and improvement of the current code Experience required: A degree in the field of computer engineering/software development Good experience with RTOS software development (e.g. QNX, freeRTOS) Strong experience working with C/C++ Experience working with medical software and software architecture is desired Fluency in English and German is strongly desired If you're interested in this position, please contact Hollie Dear for further details: hollie.dear@adaptivelifescience.com #LI-HB1  #LI-Hybrid