Quality

Head of Quality & Regulatory Affairs (m/f/d)   Location: Tuttlingen, Germany (Hybrid)   Overview:   Our client has been manufacturing innovative medical devices for over 20 years and has over 150+ employees.   Benefits: Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Holiday & Christmas Bonus + Pension Scheme Flexible Work Options: Take advantage of the opportunity work from home 2 days per week + Flexible working hours Generous Vacation Policy: 31-days vacation including 1 day off for your birthday. 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 future prospects. Continuous Evolution & Development: Wide range of development opportunities Responsible and varied tasks working in a fun and diverse team, being responsible for the compliance department Flat hierarchies and short decision-making processes enable you to achieve a lo   Tasks:   Leadership & Strategy   Head of the Compliance Department with a focus on Regulatory Affairs, Quality Management and Quality Assurance Determination of the certification strategy: Medical devices/UL 8139/Drug-Device-Combination, etc.   Product Conformity & Approvals   Responsibility for all product approvals and their maintenance in cooperation with internal and external bodies Ensuring compliance with standard requirements in close cooperation with R&D Assessment and release of technical documentation for medical devices of risk classes I-III under the MDR   Risk Management   Responsibility for conducting risk assessments for our medical devices (electrical devices & associated software) Intensive cooperation with R&D in defining risk-minimizing measures Management of periodic reviews regarding risk assessments     Your Profile:   Successfully completed degree - ideally with a technical focus (preferably with a doctorate) 7+ years of professional and project experience in the specified field of responsibility High problem-solving skills and analytical skills to identify and proactively manage complex (partly technical) challenges Leadership experience (3+ years) A high level of communication skills and enjoyment of working together across interfaces Knowledge of quality management and approval of medical devices (ISO 13485, MDR, FDA, etc.) Ideally, experience in conducting clinical trials 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 at: luke.fines@adaptivelifescience.com

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

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!  

QA/RA Specialist QA/RA Specialist for a distributor of interventional catheters and products for lipoprotein apheresis in Eschborn, Germany In this role, you will assist with day-to-day QA activities, particularly in the areas of complaint management and change control for medical devices. Apply now to join my client, the European distributor of a leading manufacturer and supplier of innovative life science products. Role Incentives Competitive Salary that reflects your skills and contributions Flexible Working Options with 40% Home Office Individual training & development opportunities Your Key Responsibilities Complaint handling as the designated Complaint Coordinator Change control activities Verification of purchased and non-conforming products Other Responsibilities Maintenance of device registration database Waste management Requirements Completed studies in Natural Sciences/ Engineering Solid knowledge and previous experience working according to MDR and ISO13485 (Certifications good to have) Min. 1 year experience in Quality Management and Regulatory Affairs, ideally in the areas of complaint management, change control, supplier control, CAPA & non-conformities, product registrations and document management Experience conducting/ participating in audits Fluent German & English (required) Reach out to Vivien Zsuzsanna 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  

Would you like to drive quality processes for a cutting-edge medical software company?   Are you passionate about contributing to the modernisation and improvement of healthcare?   We're searching for a QMB for our pioneering MedTech client in Munich! Could this be your next step?   Key Responsibilities: Serve as the Quality Management Representative, overseeing all aspects of QMS document management, including creation, revision, and approval processes Lead the CAPA process to ensure timely identification and resolution of non-conformities Coordinate both internal and external audits Provide training and ongoing support to staff on quality-related topics Conduct management reviews to evaluate and report on the compliance and effectiveness of the QMS Draft and evaluate technical documents in line with MDR, regulations for non-EU countries, US FDA 21 CFR Oversee risk management following ISO 14971   Requirements: A degree in Biomedical Engineering or a related field Experience in Quality Management for Medical Devices, including development and/or maintenance of a QMS, as well as participating in internal and external audits Strong knowledge of ISO 13485, MDR, ISO 14971, and standards such as ISO 62304, ISO 62366, Skilled in coordinating processes and providing guidance to colleagues in quality 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.

Head of Department - Quality Management System & Regulatory Affairs Location: Aachen  We are supporting a client in the MedTech industry, specializing in the development and manufacturing of innovative medical devices, in their search for a Head of Quality Management System & Regulatory Affairs. In this role, you will lead a dynamic team, overseeing quality management and regulatory processes to ensure compliance and drive continuous improvement. Key Responsibilities: Lead an interdisciplinary team of experts, fostering a culture of continuous improvement and quality. Manage the company’s Quality Management System (QMS) in compliance with international standards (ISO 13485, EU MDR, FDA), and ensure regulatory approvals for medical devices in global markets. Oversee risk management strategies and ensure the successful planning, execution, and follow-up of internal/external audits and inspections. Collaborate with cross-functional teams in product development, production, and marketing to ensure smooth product launches. Monitor trends in regulatory standards and integrate them into the company's strategic planning. Improve operational efficiency through the integration of automated software systems, enhancing transparency and regulatory compliance. Your Profile: Degree in medical technology, engineering, natural sciences, or a related field. Several years of experience in quality management and regulatory affairs within the medical device industry. Strong knowledge of ISO 13485, EU MDR, and FDA regulations. Proven leadership skills with experience managing and developing teams. Exceptional organizational, communication, and project management skills. Fluency in German and English (both written and spoken) is essential. This position offers the opportunity to lead a key department within a cutting-edge MedTech company, with a focus on driving innovation while maintaining the highest regulatory standards. 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

Senior Quality and Regulatory Affairs Manager Our client is seeking an experienced and motivated Senior Quality and Regulatory Affairs Manager to join their fast-growing medical device company in Munich, Germany. In this role, you will play a crucial part in maintaining global quality and regulatory compliance. You'll have the opportunity to collaborate with internal teams, mentor junior staff, and manage important relationships with regulatory authorities and external partners. Key Responsibilities: Manage and maintain technical documentation for product submissions, changes, and quality management (QM)-related documents. Mentor and train staff across various departments to ensure effective execution of regulatory responsibilities. Conduct compliance audits, including assessments of vendors, clients, and subcontractors. Support and manage external audits with notified bodies and competent authorities, overseeing risk management and post-market surveillance activities. Oversee the establishment, maintenance, and optimization of Quality Systems to ensure full regulatory compliance.. Act as a primary contact for regulatory agencies, assisting with negotiations and managing interactions during inspections and audits. Key Qualifications: Bachelor’s degree in Engineering, Biomedical Sciences, or a related field (Master’s degree or MBA preferred). Minimum of 4 years of experience in quality management and regulatory affairs within the medical device industry. Proven experience with regulatory submissions and approvals such as MDD/MDR. Experience with regulatory audits and a deep understanding of medical device standards. Flexible, goal-driven, and a collaborative team player focused on delivering results. This role offers a unique opportunity to contribute to a growing company and shape the development of cutting-edge medical technologies aimed at improving patient care. 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

QMB Job Description QMB For Medical Device Manufacturer in Freiburg, Germany In this role, you will oversee Quality and Regulatory processes within the company, and ensure suppliers meet relevant requirements Are you a passionate, forward-thinking RAQM professional looking to grow in your career? Are you motivated by quick and efficient decision making processes and enjoy a hands-on, independent working style? Apply now to join my client, a growing, ambitious medical device manufacturer specialising in physiotherapy! Role Incentives Company health management plan Competitive Salary A premium brand with a lot of growth potential Company Culture A young, social and highly motivated team Cooperative management style, short and quick decision-making processes Your Key Responsibilities Maintenance and development of QMS per ISO 13485 and MDR External supplier auditing and certification Risk Management and Incident reporting Other Responsibilities Employee training on Quality and Regulatory matters PRRC Auditing Requirements Fluent German & English (required) Knowledge of and experience working with ISO 13485, MDD or MDR (required) Experience with risk management, root cause analysis and CAPA management for medical (required) Qualifications or experience in medical device Quality Management as a QMB, PRRC or auditor (nice to have) 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 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