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Risk Manager Location: Frankfurt area (high degree of remote flexibility) Would you like to work for a global leader in the treatment of renal disease and support the safety of the product through a risk management process? We are currently supporting our client who is looking for a Risk Manager to join their Product Development Team. Your tasks: Plan and execute the risk management process. Create risk assessments for complaints and support the preparation of FMEAs. Support the audit of design & development and risk management sessions. Create and monitor the design control metrics in development, post-market activities, and change management. Monitor the state of the art to continuously improve product safety. Responsible for pre-production defect management (Anomaly Reports), risk analysis, and specification of countermeasures. Your profile: A degree in engineering, biology, medical technology, or equivalent. Minimum of 3 years of experience in Regulatory Affairs, Research and Development, or Risk Management. Experienced in medical device regulations (EU MDR, MDSAP, MDD 93/42/EEC, etc.) High degree of knowledge in FMEA method, and quality management and risk management standards (ISO 13485 and ISO 14971). Fluent in written and spoken English and advantage of German skills. Benefits: Very international environment. High home office flexibility and flexible working hours. Continuous support in the development. Pension scheme. 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-Remote

Regulatory Affairs Expert   Do you enjoy working with many different clients, ensuring their regulatory compliance as well as supporting them in achieving their CE-marking across the European market? Read on! Our client – a well-established Consultancy is currently looking for a Regulatory Affairs Expert to strengthen their international team.   Responsibilities: Compilation of Technical Documentations. Ensure fulfilment of EU requirements (93/42/EEC, 98/79/EC, 90/385/EEC) as well as new EU regulations 2017/745 und 2017/746. Interactive collaboration with In-house experts covering all subjects related to CE-marking of medical devices /IVDs (pre-clinicians, clinicians, QM etc.) Implement and maintain regulatory SOPs within ISO 13485. Close interaction with international clients as well as Notified Bodies and Competent Authorities. Development of creative solutions in order to fulfil client needs combined with regulatory requirements.   Requirements A degree in electrical, medical/biomedical engineering. Experience in medical device or IVD industry, preferably in regulatory affairs and/or quality management related positions; Notified Body experience Working knowledge of Electrical safety for medical device norm (IEC 60601) Previous experience supporting international registrations to include 510k. Working knowledge of ISO 14971 & IEC 62304.   If you are interested, please apply with your CV or email Dominika Wyrwinska on dominika.wyrwinska@adaptivelifescience.com.. #LI-DW1      

Medical Device Sales Manager - CDMO We are looking for a Sales Manager with experience selling CDMO services to Medical Device OEMs, could this be you? COMPANY - > 100 year history - Substantial M&A growth - Globally recognised Medical Device Design and Manufacturing companies - Europe is a primary focus for growth ROLE - Selling the CDMO offering and private branding and labeling solutions. - Targeting the European amrket and some MENA countries. - 70% new business and 30% growth of existing accounts - 2 junior sales reps that could be direct reports immediately or in the future. English is the only language requirement, all other language are a bonus. The position can be based remotely in Europe. Salary is open and flexible, it will be shaped to the individual. 30% bonus/commission. If this sounds of interest and you are experienced in selling CDMO services to Medical Device OEMs, the please do apply! owain.withers@adaptivetech.io #LI-OW1