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Senior Regulatory Affairs Manager (m/f/d) Location: Germany (Remote) Overview: Our client is a registered CRO (clinical research organisation); however, their support and services go beyond those of a typical CRO. The team are specialists in the area of medical device approval and market observation. Benefits:   Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Flexible Work Options: Take advantage of a fully remote, home office position with flexible working hours. Generous Vacation Policy: 30-days’ vacation. Recharge and rejuvenate, giving you ample time to relax and enjoy life outside work. Permanent Full-Time Position: Permanent employment in a growing company with secure prospects. Continuous Evolution & Development: Wide range of development opportunities, including the possibility of team leadership Responsible and varied tasks working in a fun and diverse team that works with a diverse range of customers with different challenges and requirements. Learning Opportunities; benefit from seminars and other educational opportunities. Tasks:   You create and update the technical documentation of medical devices according to Annex II and III of the MDR You carry out market surveillance (Post-Market Clinical Follow-up, PMS) in accordance with MDR You carry out PMCF activities Your Profile:   You have at least four years of professional experience in regulatory affairs for medical devices You have a degree in mechanical engineering, electrical engineering or medical engineering or a comparable qualification such as a scientific degree or you have at least 10 years of professional experience in the field of regulatory affairs for medical devices You have experience in the approval of medical devices, especially software as a medical device You have good knowledge of MDR and FDA requirements as well as quality management Good knowledge of IEC 62304 You are a team player and have strong communication skills You are ready to familiarize yourself with new topics and areas You have very good German skills (C2 level) and good English skills (at least C1 level) To apply or for more information, please get in touch with Luke Fines by email with a copy of your CV at: luke.fines@adaptivelifescience.com           

Technical Department Team Lead Industrial Maintenance Technical Team Lead for a medical device & chemical product manufacturer in Lorsch, Germany In this role, you will manage the in-house Engineering Team and oversee maintenance of on-site industrial machinery equipment. Apply now to join our client, a leading manufacturer known for its innovative solutions and exceptional customer service with a deep focus on sustainability in product development. Role Incentives An inspiring working environment where your ideas count Competitive Salary First-class development opportunities Career growth options Flexible working Your Key Responsibilities Drive in-house engineering improvements Diagnose and repair issues on equipment to minimize downtime Acquire, install, calibrate and validate new equipment Other Responsibilities Manage the in-house Technical Team Document maintenance activities in compliance with safety and quality standards Spare parts management Requirements Masters degree in Engineering, Industrial Maintenance, or a related field Several years’ experience in repair and maintenance of industrial machinery (e.g., filling, mixing, processing equipment) in a healthcare environment Experience with machinery installation, calibration, and validation Knowledge of mechanical, electrical, and hydraulic systems & ability to read technical drawings Interest in and hands-on engagement with implementing new technical innovations Knowledge of automation technology is an advantage Fluency in German and English is a must Reach out to Vivien Urban for more information about the company culture, and long-term development plans. Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:   Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback   We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence. If you are interested in this role, please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   Vivien.urban@adaptivelifescience.com +49 30 16639819   

Quality Manager Location: Dresden, Germany We are supporting an innovative MedTech company specializing in advancing healthcare solutions. They are seeking a Quality Manager to lead and enhance their quality processes, ensuring compliance with regulatory standards and contributing to cutting-edge developments in healthcare technology. This is an opportunity to be at the forefront of cutting-edge healthcare advancements in a flexible, growth-oriented environment. Key Responsibilities: Design, implement, and manage quality systems that ensure compliance with medical device regulations and international standards. Identify potential risks and develop proactive strategies to maintain compliance and safety throughout the product lifecycle. Work closely with cross-functional teams to embed quality into all phases of development and operational workflows. Maintain key documentation processes, ensuring precision and consistency across all quality-related activities. What is required: A solid background in quality management within a technical or medical field, with a comprehensive understanding of regulatory frameworks like MDR and ISO. A degree in Medical Technology, Quality Management, Engineering, or a similar discipline. A detail-oriented, structured approach to work, with the ability to prioritize tasks and maintain focus on solutions. A proactive team player, eager to work across departments to ensure quality excellence. What is offered: Enjoy hybrid flexibility and adaptable schedules. Contribute to innovations that directly enhance patient outcomes. Access continuous professional development opportunities as part of a growing organization. A competitive salary, and 30 vacation days. If you’re ready to take the next step in your career and contribute to transformative advancements in healthcare, I would love to hear from you.   Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.   If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid

Senior Clinical Research Associate Location: Geneva (remote flexibility) Are you passionate about advancing cardiovascular health and driving innovation in clinical research? We’re supporting a client in the cardiovascular health space, based in Geneva who is looking to for a Senior Clinical Research Associate. The CRA will play a key role in ensuring the success of clinical trials, overseeing investigational site activities, and ensuring compliance with international standards, local regulations, and organizational procedures. Your responsibilities:  Leading study start-up and site activation processes, including creating and approving essential trial documentation, such as ICF templates and TMF plans. Ensuring high-quality data collection, overseeing vendor management, and maintaining progress throughout study phases to meet strict timelines. Conducting on-site monitoring visits, providing training to site personnel and vendors, and preparing detailed reports to ensure trial activities comply with GCP and regulatory requirements. Auditing and maintaining regulatory and trial documentation to ensure compliance with global and regional standards. What is required:  Strong knowledge of Good Clinical Practices (GCP), FDA, ISO, and European regulatory standards, with experience in high-risk Class III medical devices. Proven expertise in the cardiovascular field. Excellent analytical and problem-solving skills, with attention to detail and experience managing regulatory documentation. Strong communication and organizational abilities, capable of managing complex trials and collaborating effectively with cross-functional teams. Fluency in English required; proficiency in German or French is a strong advantage. Willingness to travel occasionally What is offered:  Remote flexibility. A collaborative and supportive work environment with opportunities for career growth and development. A competitive compensation package, including performance bonuses and other benefits.  If this sounds like the next step in your clinical research career, let’s connect! Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.   If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Hybrid

Are you an experienced Embedded Software Developer with expertise in C++/Linux and a passion for advancing medical technology? Do you want to contribute to groundbreaking solutions that improve access to sight-saving treatments for patients worldwide? Join our client’s team and play a vital role in shaping the next generation of innovative retinal treatment devices! Key Responsibilities: Develop, maintain, and verify embedded software solutions for cutting-edge medical systems. Conduct feasibility studies, design, implement, and document software solutions. Collaborate with clinical, product design, optics, and hardware teams for seamless system integration. Ensure smooth deployment of software solutions from production to global customers. Drive innovation by implementing high-quality, automated medical treatment features. Requirements: 5+ years of professional experience in embedded software development. Expertise in programming languages (C/C++ essential; C# a plus) and software architecture. Proficiency in build systems (CMake) and agile development methodologies. Experience interfacing and communicating with peripheral hardware (e.g., cameras). Strong skills in multithreading, Linux, performance optimization, and test-driven development. Familiarity with scripting (e.g., Python) and computer vision is a plus. Quality-focused with excellent attention to detail, communication, and teamwork skills. Experience in regulated environments e.g. medical device, automotive or aerospace.  Fluency in English and German language skills are an advantage. What’s in it for you? A dynamic and innovative role in a growing company operating in startup mode with R&D at its core. Opportunities for personal growth and initiative in interdisciplinary, agile teams with flat hierarchies. The chance to work with advanced laser technologies while making a meaningful impact on healthcare. If you’re ready to take your career to the next level and contribute to life-changing medical advancements, apply now and/or contact Hollie Dear at Adaptive Life Science for more information!

Are you an experienced Senior Project Manager with a passion for driving customer success in the healthcare IT sector? Do you thrive in coordinating complex projects, fostering customer relationships, and ensuring seamless implementation of cutting-edge digital health solutions? Join our client’s innovative team and make a meaningful impact in revolutionizing healthcare through AI-assisted diagnostics!   Key Responsibilities: Take ownership of projects post-sales, serving as the main point of contact for customers and partners. Support customers with inquiries and troubleshooting throughout the project lifecycle. Coordinate projects by maintaining clear communication, tracking milestones, and ensuring timely delivery. Conduct meetings, presentations, project kick-offs, and workshops with stakeholders. Collaborate with application specialists to organize training sessions and adapt templates. Oversee system installation in coordination with technical advisors. Ensure successful implementation through training, system setup, and smooth handover. Build and maintain long-term, trusted relationships with customers and partners. Requirements: A Bachelor’s or Master’s degree in IT, Business Administration, or a related field. 5+ years of project management experience managing multiple projects simultaneously, ideally in the healthcare IT sector. Exceptional communication and presentation skills. A reliable, independent work style with a strong focus on customer success. Fluency in German and English. What’s in it for you? Work on an innovative product transforming healthcare with AI-assisted diagnostics. Be part of a growing, well-funded organization supported by top-tier investors and EU grants. Collaborate with a positive, highly qualified, and international team. Enjoy benefits such as a job ticket, job bike, corporate benefits portal, and more. Access to an individual development budget to support your career growth. Flexible working hours with a hybrid working model (up to 100% remote). If you’re ready to take on an impactful role in a dynamic environment, apply now and/or contact Hollie Dear at Adaptive Life Science for more information!

Are you a skilled Compliance Manager in the MedTech space? Do you want to lead compliance efforts, oversee audits, and ensure processes align with the highest regulatory standards? Join our client’s innovative team and play a pivotal role in maintaining the integrity and security of cutting-edge solutions that improve the lives of millions of patients worldwide! Key Responsibilities: Develop and maintain compliance management systems to uphold regulatory standards. Monitor legal developments and security threats, ensuring company preparedness. Conduct internal audits and oversee external certification processes. Lead compliance training programs across the organization. Maintain detailed records for internal reviews and external regulatory authorities. Serve as the primary point of contact for compliance, information security, and quality management. Coordinate compliance-related meetings and ensure clear communication of updates. Support the creation of technical documentation to meet market regulations. Evaluate suppliers and third-party services for compliance with quality and security standards. Drive continuous process improvements based on audit feedback and regulatory changes. Requirements: 2+ years of overseeing compliance and risk management in healthcare or technology fields. Hands-on experience with ISO certifications (e.g., ISO 13485, ISO 27001). Proven ability to lead compliance projects and meet timelines. Strong understanding of frameworks for information security and quality management. Ability to effectively communicate with internal stakeholders and external authorities. Skilled in identifying compliance risks and implementing preventive measures. Native German and fluent English. If this sounds like the right opportunity for you, please apply and/or contact Hollie Dear at Adaptive Life Science for more information!  

Are you an experienced Technical Writer looking to make an impact in the medical field? Do you want to create clear, accurate documentation that supports both product development and user training for life-saving medical devices? Join a dynamic team and contribute to the success of cutting-edge medical products! Key Responsibilities: Develop comprehensive documentation for technical products, including user manuals, guides, and technical specifications. Collaborate with engineers, product developers, and other stakeholders to ensure accuracy and consistency. Edit and revise existing content for clarity, consistency, and compliance with standards. Ensure all documentation meets regulatory and compliance requirements. Requirements: Bachelor's degree in Biomedical Engineering, or a related field. At least 3 years of experience in technical writing within the medical device industry, including instructions for use, patient brochures etc. Excellent written communication skills and the ability to simplify complex concepts. Familiarity with regulatory standards for medical devices. Fluency in German and English.   If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.