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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!  

(Senior) R&D Engineer (m/f/d) Location: Mainz, Germany (Hybrid) Overview: This company is one of the leading developers and manufacturers of medical devices and aids for patients. The premium product portfolio focuses on patient care in the clinic and in the homecare sector. The company has a 60-year history and has already been voted into the top 100 German SMEs three times. Benefits:   Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Annual pay reviews are to be expected. Flexible Work Options: Take advantage of the opportunity to work from home 2 days per week after your probation period Generous Vacation Policy: 30-days’ vacation. Recharge and rejuvenate, giving you ample time to relax and enjoy life outside work. Health-Management Program: To make sure employees find the right balance between work and everyday life (running groups, yoga, burnt-out prevention, and various other strategies) + access to a discount website covering a wide range of services/partners Permanent Full-Time Position: Permanent employment in a growing company with secure future 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 Team Events; benefit from being part of a wider global operation with summer and winter company events. Tasks:   You work on development projects for passive medical products made of plastics - from conception, design, and prototypes to series production for clinical application You create the relevant technical development documentation in accordance with regulatory requirements (e.g. DIN EN ISO 13485, MDR, CFR820) You work on technical concepts, realisation in 3D CAD, prototypes and verification and validation measures Your Profile:   You have a completed engineering degree with a focus on plastics technology or medical technology or comparable qualifications You have several years of practical experience in managing projects 5 + years of professional experience in R&D for Medical Technology with a focus on plastics components In addition to technical know-how, you have good analytical and methodological skills as well as a structured, solution- and result-oriented way of working You enjoy working in a team and impress with your communication skills, enthusiasm, motivation and conflict-resolution skills You have very good German and fluent English skills, both written and spoken Experience working in an international environment 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           

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.  

Instructional Designer (Digital Training) Location: Hamburg area (hybrid flexibility) Are you an innovative Instructional Designer with expertise in digital training media? Do you excel in Articulate Storyline, Adobe CC, and H5P to create engaging and high-quality digital learning experiences? Our client, a global leader in healthcare diagnostics, is renowned for its groundbreaking products and dedication to enhancing the healthcare journey. They’re currently seeking an International Instructional Designer to join their digital training team and make a significant impact in advanced e-learning development. Main responsibilities: Develop, design, and produce engaging digital training content for medical diagnostics and healthcare topics Create and integrate graphics, animations, videos, and interactive elements into training modules Lead digital training project management, from conceptualization to release, ensuring high-quality output Collaborate with international instructional design experts to refine and innovate training solutions Continually improve workflows to maintain and elevate the quality of training media produced What is required: Advanced skills in digital training development with expertise in web-based training using Articulate Storyline. Strong graphic design skills with Adobe Photoshop, Illustrator, and After Effects, along with basic video production and post-production experience. Solid experience in technical and scientific storytelling, with resourceful communication skills to collaborate effectively with SMEs. Experienced in planning and coordinating training media productions. Adaptable and quick learner, open to continuous skill growth and enthusiastic about contributing to an international, intercultural team. 3D design skills with tools like 3DS Max, Cinema 4D, or Blender would be an advantage. Fluency in English (written and spoken). Willingness to travel globally (up to 30%). What is offered: Assistance for relocation to the Hamburg area. Hybrid working model with 30 days of annual leave. Broad learning and development opportunities, including access to an on-site training campus. Christmas and holiday bonuses, childcare support, subsidized pension plan, company discounts, and canteen lunch subsidies. In-house gym, sports courses, massages, psychological support, and general health management services Public transport subsidy, bike leasing options, and free parking. If you enjoy leading your own projects, collaborating with subject-matter experts, and working within a dynamic, international team, this opportunity may be a perfect fit! 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 passionate about ensuring safety and quality?   Do you enjoy navigating regulatory standards and managing product compliance?   Join our innovative client and play a crucial role in ensuring their devices meet all regulatory requirements and safety standards.   This position is ideal for someone with an engineering background, with a solid understanding of regulatory requirements who thrives in a detail-oriented, cross-functional environment!   Key Responsibilities: Identify and interpret compliance standards for our products. Assess standard updates and determine necessary adjustments with relevant departments. Develop product specifications for new products based on industry standards. Oversee approvals and maintain certifications by collaborating with both internal teams and external authorities. Work closely with certification agencies (e.g., UL, TÜV) to meet industry requirements. Plan, coordinate, and conduct risk assessments for our medical devices (including electronic components and software). Support product development in defining and validating risk-reducing measures. Schedule and perform routine reviews of risk assessments.   Requirements: Bachelor's degree in Engineering e.g. Electrical Engineering or equivalent technical training with relevant professional experience. Familiarity with regulatory requirements for medical devices or electronic appliances. Excellent communicator and team player who enjoys interfacing between development and regulatory compliance. 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.

Are you an accomplished Senior Software Architect looking for your next challenge? Do you want to lead the design and development of ground-breaking software solutions for innovative medical devices? Join a leading MedTech company and play a pivotal role in shaping the future of healthcare technology! Key Responsibilities: Lead the design and architecture of complex software systems for medical devices, ensuring they meet industry standards and regulatory requirements (e.g., FDA, ISO 13485). Collaborate with cross-functional teams, including product management, hardware engineering, and quality assurance, to define system requirements and architecture specifications. Develop and maintain software architecture documentation, ensuring clear communication of architectural decisions and design rationale. Drive continuous improvement in software development practices, including design patterns, coding standards, and best practices for scalability, security, and performance. Mentor and guide junior software engineers, fostering a culture of innovation and technical excellence within the team. Perform risk assessments and implement mitigation strategies to ensure product safety and compliance. Oversee the integration of third-party tools and technologies, ensuring seamless compatibility with existing systems. Collaborate with regulatory and quality teams to support validation and verification activities for software components. Ensure software systems are maintainable, modular, and adaptable to future product enhancements and evolving market needs. Lead technical discussions and decision-making processes, balancing long-term architectural goals with short-term project deadlines. Requirements: Bachelor's or Master's degree in Computer Science, Software Engineering, or related field. Minimum of 5 years of experience in software engineering, with at least 3 years in a senior or lead architectural role, preferably within the medical device industry (or a regulated industry). Strong experience with embedded systems, real-time operating systems, and software development lifecycle in a regulated environment. Expertise in software design principles, architectural patterns, and scalable system design. Proficiency in programming languages such as C++,  Python, JSON and experience with embedded programming. Knowledge of software testing, debugging, and profiling tools. Strong understanding of security, data integrity, and privacy in medical device software. Familiarity with industry standards and regulatory requirements (FDA, IEC 62304, ISO 14971) is preferable.  Excellent communication and leadership skills, with a track record of collaborating effectively across teams. 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.

Quality Management and Regulatory Affairs Group Lead Quality Management and Regulatory Affairs Group Lead for a medical device & chemical product manufacturer in Lorsch, Germany In this role, you will for managing the Quality and Regulatory Departments and ensure product quality and regulatory compliance by maintaining certifications, managing technical documentation and overseeing the Quality Management System (QMS). 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 Flexible working Your Key Responsibilities Maintain the marketability of all products by verifying compliance with customer specifications and regulatory requirements Monitor and maintain technical documentation in accordance with legal requirements Oversee and improve the quality management system (QMS) to ensure compliance with regulatory standards Ensure adherence to the QM system and internal processes, including project management and implementation of quality policies and objectives Other Responsibilities Lead group management and team building Contribute to the development and execution of the overall corporate strategy Represent the company in external communications with authorities and regulatory bodies Requirements Relevant degree in Life Sciences, Engineering, Quality Management, or related field Minimum 5 years of experience in quality and regulatory compliance within BioTech/MedTech/Pharmaceutical sectors Strong knowledge of ISO 13485, GMP, and MDD/MDR standards, with expertise in quality assurance, compliance, and market authorization processes Proven skills in building and improving Quality Management Systems Structured, independent leader with experience in team management, project oversight, and cross-functional collaboration. Fluency in German and English Knowledge of other relevant standards e.g. BPD/BPR, Cosmetics Regulation, German manufacturing authorization are a plus! 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  #LI-VU1  

Head of Regulatory Affairs  Location: Geneva, Switzerland Our client, a leading innovator in the design and manufacturing of combination MedTech products with a broad and ever-growing product portfolio, is seeking a Head of Regulatory Affairs to manage the EMEA & US operations and provide strategic input to the executive leadership team. This role involves overseeing the full life cycle of new and existing products.  Main Responsibilities: Develop and implement regulatory strategies aligned with business objectives, supporting pre and post market projects and influencing across TechOps to drive urgency Oversee regulatory submissions and ensure compliance with EU & US standards Monitor regulatory changes and adapt strategies accordingly Collaborate with cross-functional teams on new product development Mentor and lead the Regulatory Affairs team and manage regulatory responses and ensure effective team communication Support QMS optimization and continuous improvement – key partner for Quality Operations Requirements and Skills: 10+ years of experience in Regulatory Affairs within Medical Technology / Combination Products with pre and post market exposure. Relevant education and experience to act as PRRC an advantage. Extensive knowledge of EU regulations and experience negotiating with regulatory agencies and Notified Bodies (FDA experience a plus) Proven leadership abilities, including team management experience, mentorship, and strong decision-making skills – strong communicator with the gravitas to deal with multiple internal and external stakeholders Strategic thinking and the ability to thrive in a dynamic, fast-paced environment Fluent in English, French a plus   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 Etienne van Wyk for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry. etienne.vanwyk@adaptivelifescience.com #LI-EV1