Johner Institute helps medical device manufacturers to 
- compile, review and improve technical documentations: risk management files (ISO 14971), usability files (FDA, IEC 62366-1), software documentation (FDA, IEC 62304), physical safety (IEC 60601-familiy), clinical evaluations
- establish, audit and improve quality management systems (ISO 13485, 21 CFR part 820)
- perform usability testing in Europe and the USA
- plan and conduct clinical investigations
- perform post-market surveillance, regulatory affairs update

Johner Institut GmbH

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seo-marketing

Johner Institut GmbH is a German regulatory and training services firm specializing in medical devices and in vitro diagnostics (IVD). The company helps manufacturers with regulatory affairs, market access (EU/UK/CH/US), quality and information security management systems, technical documentation, clinical and performance studies, product testing (biocompatibility, electrical/EMC, IT security) and penetration testing, and provides authorized-representative/legal-manufacturer and outsourcing services. It also offers education (seminars, e-learning, Auditgarant templates), RegTech/SaaS tools for regulatory intelligence and post-market surveillance, and consulting to implement AI/AI Act compliance and digitalization for medtech clients.

Johner Institute helps medical device manufacturers to 

- compile, review and improve technical documentations: risk management files (ISO 14971), usability files (FDA, IEC 62366-1), software documentation (FDA, IEC 62304), physical safety (IEC 60601-familiy), clinical evaluations

- establish, audit and improve quality management systems (ISO 13485, 21 CFR part 820)

- perform usability testing in Europe and the USA

- plan and conduct clinical investigations

- perform post-market surveillance, regulatory affairs update

• Operational planning of our trade show appearances
• Organizing travel, accommodation and deployment schedules for our team during trade shows
• Planning and organizing our in-house event "Medical Device Days"
• Administrative and organizational tasks in the office
• Planning and organizing team days

Office and Event Manager – Focus on Trade Fair Organization, Part-time

As Office- und Eventmanager:in, you organize Messeauftritte and events for the Johner Institut in Konstanz. Managing logistics and administrative tasks while supporting team happiness and efficiency.

security-engineer

• Advise medical device and IVD manufacturers on implementing cybersecurity and software lifecycle requirements
• Create and review cybersecurity documentation, lead workshops, and develop practical templates and processes for secure software development
• Support our clients in implementing and deploying cybersecurity processes in accordance with IEC 81001-5-1, including interfaces with MDR/IVDR and ISO 14971
• Review, create, and revise cybersecurity documents such as cybersecurity concepts and risk analyses
• Independently further develop regulatory concepts such as templates and guidelines
• Conduct workshops, deliver training for clients, and share your expertise through technical articles

Consultant – Cybersecurity, Regulatory-Compliant Software Development

Consultant for cybersecurity and compliant software development supporting medical device manufacturers. Creating security documentation and facilitating workshops in a hybrid or remote setting.

• You manage the operational planning of our trade show appearances, e.g., registrations, coordination with event organizers, and coordination of booth construction, materials and logistics
• You organize travel, accommodations and scheduling for our team during trade shows while keeping budgets, deadlines and all organizational details in view
• You plan and organize our own event, Medical Device Days — from preparation and coordination with service providers to on-site execution
• As Office Manager, you are the heart of the office and contribute to the satisfaction and well‑being of our employees and clients
• To ensure smooth office operations, you handle administrative and organizational tasks such as mail processing, ordering office supplies, managing the digital filing system and liaising with building management, the cleaning service and other external partners
• You plan and organize our team days from the initial concept to the final details, strengthening our company culture and creating the basis for memorable shared experiences

Office and Event Manager, Trade Fair Organization

Office and Event Manager responsible for organizing trade fair appearances and events in Germany. Ensuring smooth operations and contributing to team satisfaction and organizational culture.

product-manager

• Coordination and communication with the product and development teams as well as marketing and sales
• Further development of the product vision, strategy and roadmap for the SaaS product
• Understanding customer and user needs, validating hypotheses, and designing solution approaches
• Support in requirements analysis as well as in proposal and sales processes
• Leading the development team and the Technical Product Owners, coordinating collaboration among stakeholders
• Ensuring relevant regulatory changes are considered in the product context and translated into actionable product requirements

Senior Product Manager – B2B SaaS

Senior Product Manager coordinating the product vision and roadmaps for a B2B SaaS product. Engaging with stakeholders and leading the development team to meet enterprise customer needs.

sales

• You lead our B2B sales team for our SaaS products and scale the sales organization — from positioning and pricing through pipeline/forecast to closing.
• You work closely with Product, Marketing and Development and translate market and customer feedback into measurable improvements.
• You develop and own the sales strategy for our digital SaaS products (Radar solutions as well as Auditgarant).
• You analyze market and competitive situations and identify new target groups and business opportunities.
• You optimize pricing, licensing, subscription and service models with a focus on SaaS.
• You develop and implement sales structures and processes to sustainably drive our growth (including KPIs, forecasting, reporting).
• You systematically manage our existing customers, develop strategic key account relationships and are responsible for customer retention, contract renewals as well as expansion and growth opportunities.
• You leverage upselling and cross-selling potential of product features and licenses and develop tailored strategy plans for our customers.
• You generate leads and drive systematic new customer acquisition.
• You are responsible for building and managing funnel analytics across the entire customer journey.
• You conduct product demos, webinars and presentations.
• You negotiate contracts and successfully close license agreements.

Head of Sales – B2B SaaS

Head of B2B Sales leading a SaaS team at Johner Institut. Driving sales growth and collaborating across product, marketing, and development teams.

events

• Handling administrative and organizational tasks, such as mail processing and ordering office supplies
• Managing the digital filing system and liaising with property management, the cleaning service, and other external parties
• Organizing and coordinating our presence at trade fairs and conferences
• Planning and organizing our team days from the initial idea to the final details

Office and Event Manager – Part-time

As an Office and Event Manager, responsible for organizing, coordinating events, and ensuring operational efficiency. The company supports medical device manufacturers in product development.

Johner Institute helps medical device manufacturers to  - compile, review and improve technical documentations: risk management files (ISO 14971), usability files (FDA, IEC 62366-1), software documentation (FDA, IEC 62304), physical safety (IEC 60601-familiy), clinical evaluations - establish, audit and improve quality management systems (ISO 13485, 21 CFR part 820) - perform usability testing in Europe and the USA - plan and conduct clinical investigations - perform post-market surveillance, regulatory affairs update

Johner Institut GmbH

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6 jobs found

Office and Event Manager – Focus on Trade Fair Organization, Part-time

Johner Institut GmbH

Consultant – Cybersecurity, Regulatory-Compliant Software Development

Johner Institut GmbH

Office and Event Manager, Trade Fair Organization

Johner Institut GmbH

Senior Product Manager – B2B SaaS

Johner Institut GmbH

Head of Sales – B2B SaaS

Johner Institut GmbH

Office and Event Manager – Part-time

Johner Institut GmbH