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Project Manager for Medical Device Development
SchwerinGermany65,000EUR - 75,000EUR
Project Manager for Medical Device Development
Are you an engineering professional with project management expertise and a desire to innovate in a dynamic work environment?
Our client located in northern part of Germany is currently seeking a Project Manager to lead the development of respiratory devices, ensuring structured processes, collaboration, and adherence to international standards.
Tasks:
Leadership in project management for medical device development
Execution of all phases in a defined and structured development process
Active participation in risk management following ISO 14971
Collaboration with external development partners and customers
Co-responsibility for product design, comprehensive testing, validation, and compliance with CE regulations and harmonized standards
Preparation of technical documentation for international approvals
What is required:
Degree in engineering or equivalent
In-depth technical understanding
Previous experience working within Project Management in MedTech.
Proficiency in both written and spoken German and English
What is offered:
Flexible working hours and potential for remote work
Engaging tasks in growing company and development opportunities
Dynamic work environment with creative freedom
Annual holiday entitlement of 30 days
Attractive social benefits
If this sounds like you, please do not hesitate and send the application.
If you have any questions regarding the position, please contact:
Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com
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QM/QA Specialist
StuttgartGermany50,000EUR - 60,000EUR
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
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Regulatory Affairs Specialist
HeidelbergGermany€65,000
Regulatory Affairs Specialist
Are you passionate about bringing safe and effective medical devices to market with speed and agility?
My client, a global leader in the design, manufacture, and distribution of cutting-edge mobility devices is seeking a promising Regulatory Affairs Specialist to join their European team.
Ready to put your skills to work?
Your Tasks:
Implement quality system components focused on regulatory compliance with MDR 2017/745, ISO 13485 and ISO 14971
Manage projects and activities for the improvement of products and processes from a regulatory standpoint
Monitor and ensure the compliance of regulatory requirements (Europe, Switzerland & UK)
Manage CAPA system, track recalls and FSCAs
Participate in risk assessment activities such as UFMEA
Collaborate with the Quality Director Europe to ensure documentation is compliant
Assist in liability claim investigation and document collection
Your profile:
Fluent in English and at least intermediate knowledge of German
2+ years professional experience in regulatory affairs or quality management relating to medical devices
Thorough knowledge of regulatory requirements (e.g. MDR, ISO 13485 & ISO 14971)
Computer proficiency with MS Office
Strong communication skills, good organizational skills, analytical thinking and a high level of reliability
Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.
vivien.urban@adaptivelifescience.com
+49 30 16639819
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Quality Specialist
TuttlingenGermany€50,000
Quality Specialist
Overview
With roots dating back to 1930s, our client is dedicated to specializing in high-quality endoscopy products. With them, you can enjoy the personal benefits of creative freedom, collaboration within a collegial team, and the security of our international group structure as well as experience innovation, access tailored training for professional and personal growth, and work in modern, ergonomic spaces with additional perks. Would you like to elevate your career by expanding expertise in quality management, supplier quality and technical documentation, engaging with a diverse product portfolio? This is your chance!
Tasks
Maintain and further develop the quality management system in accordance to ISO 13485
Support and participate in internal and external audits (e.g. certifications)
Ensure compliance with applicable industry regulations and requirements as well as legal norms and guidelines
Maintain work instructions and procedural
Take an active role in the creation and maintenance of technical documentation
Represent the company externally during audits to prospective suppliers, partners or regulatory authorities
Your profile
Apprenticeship or vocational training as an industrial clerk, complemented by additional training and interest in technology and medical products or equivalent
Experience in MedTech industry and in areas such as Quality Management, Audits and Technical Documentation
Solid foundational knowledge of relevant regulatory and normative requirements (MDD, MDR, ISO 13485 etc.)
Team player who can also work independently
Fluency in English and German
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
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Area Sales Manager Italy
MilanoItalyOpen to Discussion
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
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Account Manager RDx Germany
MannheimGermanyOpen to Discussion
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
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Logistics Manager
StuttgartGermany€70,000 - €90,000 DOE
Logistics Manager (m/f/d)
Location: Baden-Württemberg, Germany | Hybrid working model
Salary: Circa €70,000 - €90,000 DOE
Overview:
Our client is a startup company in the medical technology industry whose goal is to improve the quality of life of cardiovascular patients and to provide medical staff with the best possible support.
Benefits:
• An interesting and varied task
• Flat hierarchies in a committed and cooperative team
• Opportunities for professional and personal development
• An attractive remuneration
• Flexible working hours / Hybrid working for increased work-life balance
• Exciting projects with large levels of responsibility
• A chance for you to leave a lasting impact on a company by helping to setup their supply chain network
• 30 vacation days per year
• Modern, ergonomic workplaces, employee laptop and company cell phone
Tasks:
• Development and definition of strategies to further build up the logistics network around transport, distribution centers and storage (including collaboration with external logistics service providers (3PL))
• Optimization of operational (international) structures to ensure the smooth running of our supply chain
• Digitization of “manual” processes to make analysis data easier to provide as a basis for decision-making
• Active control of the stability criteria demand/stock and on-time delivery and, as a result, avoidance of under-stocking
• Assessing logistical risks and taking countermeasures to ensure smooth business operations
• Responsible for the operation of our small regional warehouse in Stuttgart
Your Profile:
• Completed studies, e.g. (industrial) engineering, business administration, logistics or many years of practical knowledge, which you have supplemented with relevant training
• Several years of experience in logistics for a medical technology company or a company with a similarly regulated environment
• Knowledge of Incoterms, customs regulations, international export regulations (especially to and from the USA), compliance with trade regulations and strategies for designing distribution centers and warehousing (including dealing with external logistics service providers (3PL))
• Knowledge of setting up logistics modules in the ERP system including the Warehouse Management System (WMS)
• Experience in dealing with Class III medical technology materials and products is an advantage
• Strong communication skills, a high degree of independence and fun in literally rolling up your sleeves and getting stuck in
• Willingness to travel occasionally
• Confident handling of common MS Office applications (Word, Excel, Powerpoint, Teams) and overall high IT affinity
• Knowledge of English at level B2-C1 of the European Framework of Reference for Languages, knowledge of German at at least level B1
To apply or for more information please contact Luke via email on: luke.fines@adaptivelifescience.com
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Senior RA Specialist
JenaGermany60,000EUR - 70,000EUR
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
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