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Medical Affairs Director/Senior Manager Are you an expert in Medical/Clinical Affairs in Class III Implantable Devices? Are you looking to take your next step into a leadership role? Do you want to work with a global technology leader in regenerative medicine? We are currently supporting our client headquartered in Germany to strengthen their clinical/medical affairs function. This is a remote role, so you can be based anywhere in Germany but must be willing to travel from time to time. Does this sound like your next career step? Tasks Management of a small team (2-5 employees) Ensure regulatory compliance for clinical trials and medical products on the market in accordance to MDR, TGA and FDA Pre-market and post-market clinical projects, including medical writing, CERs, PMS, and PMCFs Clinical trial project management (documentation, budget planning, collaboration with stakeholders on an international level as well as CROs) Reimbursement and compliance (Europe, especially Germany) Your profile Degree in a scientific field such as biomedical, biology, medicine, medical engineering or a comparable field of study Experience in clinical (e.g. CER), regulatory affairs, bio-medical publication or medical writing, especially for class III implants Strong communication skills and project management experience Team player who can also work independently Knowledgeable in MS Office Fluency in English, 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  

Are you a specialist in the cardiovascular field? Would you like to join a dynamic healthcare company who are innovating in the field to help transform treatment options for patients? Currently, our long-standing client are searching for a Clinical Application Specialist to join them and support their mission! *Can be based in Germany, or France with 50-60% travel expected. Focuses: Act as the designated expert on the device and educate hospital workers by imparting your knowledge. Train medical professionals in the handling, insertion, and troubleshooting of the device. Oversee in-service education initiatives and one-on-one training sessions in a hospital setting. Find prospects for the adoption of therapies in conjunction with other internal teams in Clinical Affairs and R&D. Work together with R&D to offer input on new device development and feature enhancements. Arrange and participate in patient screening meetings and offer assistance with device suitability and patient selection. Requirements: 5+ years of experience in Clinical Support/Clinical Application/Field Clinical activities within the cardiovascular field OR clinical experience as a Cardiovascular Technician, Physician Assistant or CV Sonographer. Strong customer-facing experience and great communication skills. Experience in clinical engineering from roles connected to the industry that aid in clinical case assistance and development. Experience in presenting clinical and medical information. Willingness to travel (50-60%). Fluency in English is required. If you're interested in this position, please apply here and/or contact Hollie Dear at Adaptive Life Science for more information. #LI-HB1  #LI-Remot

QM/QA Specialist Overview Our client has been developing and manufacturing implants, abutments and other components for suppliers for more than 25 years. Are you a working student or intern graduating this year and wanting to take your first step in Quality Management in the medical device industry? This is your chance! Tasks Maintenance and development of the quality management system in accordance with ISO 13485 Documentation management including risk management FMEA SOPs and trainings Process validation and monitoring Supplier management Complaint handling and CAPA management   Your profile Technical background with experience in Quality Management, Quality Assurance, CAPA or Risk Management in the medical device industry Familiarity with Norms and Standards like ISO 13485 Fluent in German and English Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management. may-lynn.ck@adaptivelifescience.com +49 30 1663 7750 #LI-MC2  

Our client is a global respiratory diagnostics leader and is currently looking for an Area Sales Manager Italy. 2 Job Summary The core responsibilities of this position are to be responsible for sales and business In assigned field, manage direct sales/agents/dealers, and drive the overall success of the business, In line with the Company's commercial strategy. 3 Required Qualifications: Bachelor's degree +5 years experience ln managing business operations, business development, and sales In healthcare market Demonstrate in-depth experience, knowledge and skills in sales management Able to work independently and determine work priorities Apply knowledge and skills to coordinate and drive sales partners towards focus goals and objectives In-depth experience, knowledge and skills In Healthcare market Team working skills Interpersonal and analytical skills 4 Objective: Drive the business growth setting short and long-term goals, in line with focus product segments and sales objectives 5 Essential Duties (Primary Tasks) Maximize sales orders, margin, market share, customer satisfaction of given modality and business solutions in assigned area. Coordination of sales partners Coordination of regional and aggregated tenders Develop good long term customer relationships, and high customer satisfaction whilst utilizing to optimum level resources in the team and Company. Support sales of assigned product range and business solutions to customers within area Organize product demonstrations, sites visit and follow up. Track market effectively and provide accurate current and forecasts data using information tools available. Communicate market information effectively to/from the field Including competitor data. Communicate effectively with members of Customer Service/marketing to maximize all sales potential Ensures knowledge of and compliance with Company policies and quality processes   Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic sanela@adaptivelifescience.com +4915123483158 Mobile #LI-SH2 #LI-Hybrid  

Our client is a global respiratory diagnostics leader and is currently looking for an  Account Manager RDx Germany in Baden-Wuerttemberg and in Berlin.  Experience: Technical and / or commercial  sales Experience in complex structures within the hospital environment Safe dealings with customers Ability to move customers to action Strong sales performance Strong sales  mindset Willingness to travel incl. overnight stays Knowledge:        Sales negotiations and deals with buyers in a hospital, doctors, as well as other decision-makers. Knowledge of Medical Devices Low Germany Safe handling of MS Office applications Word,Excel, PowerPoint and Outlook. Knowledge of spoken and written English. Goals of the job: Achievement of the specified sales targets in the assigned sales area. Strong focus on numbers an goals Team player in a Vyaire structure Improve patient outcomes and provide greater value for our customers Maintaining and expanding Vyaire's market position. Take care of existing customers Acquisition of new customers Work to be carried out (main tasks): Consulting and sale of Vyaire lung function (PFT) and ergospirometry (CPET) products. Sales negotiations and deals with purchasers, general practitioners and other decision-makers. Planning and execution of trial orders Participation in trade fairs Independent planning of trips, if necessary also with overnight stays Reporting of business-relevant numbers - regular forecast – Maintaining “Salesforce” Maintaining and Evaluating a Project List Market and competition monitoring Please apply with your CV or contact Sanela Hasanovic for further details on this opportunity: Sanela Hasanovic sanela@adaptivelifescience.com +4915123483158  Mobile #LI-SH2 #LI-Hybrid  

Senior Regulatory Affairs Specialist Location:   Would you like to work for a global healthcare leader in point of care diagnostics?  We are currently supporting our client who is looking for a Senior Regulatory Affairs Specialist to join their Diagnostics Division in Jena, Germany. Your tasks: Preparing and submitting technical files and communications to the Notified Body and regulatory agencies Supporting the regulatory department for efficient and compliant business processes Contributing to process/product improvement projects and risk management Assisting with label development and review for compliance Building strong relationships with internal and external stakeholders Your profile: Bachelor’s degree (BA/BS) from an accredited University Minimum of 2 years experience working in Regulatory Affairs with medical devices (e.g. with MDR or IVDR) Strong communication skills in English and German Strong attention to detail and a positive, flexible mindset Team player, preferably with experience in project- and team management Basic understanding of IVD regulation and experience generating quality documentation is a plus! Benefits: Meaningful Impact: contribute to improving patient well-being Career Growth: international opportunities in a fast-growing industry Attractive Benefits: comprehensive package including pension and stock options Global Recognition: join a globally recognized, diverse, and inclusive workplace Collaborative Environment: work with a dynamic, skilled team in an open and efficient culture If you feel this role was made for you, apply with your CV or contact Vivien Urban for further details or additional vacancies in the MedTech industry. No CV? No problem - you can leverage your LinkedIn profile instead. vivien.urban@adaptivelifescience.com #LI-VU1

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