Senior Consultant – Regulatory Affairs, Medical Devices, Software, AI

Job not on LinkedIn

🔥 1 minute ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🤖 Artificial Intelligence

👻 Ghost score 10%

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Johner Institut GmbH

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2005

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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.

📋 Description

• Develop regulatory approval strategies for medical devices and IVDs in the EU, the USA, and international markets • Support the approval of medical devices, including software as or in a medical device (SaMD / SiMD) and AI-based functions • Translate regulatory requirements into concrete next steps for Regulatory Affairs, Development, Quality Management, and Product Management • Prepare and review technical documentation and regulatory submission dossiers • Assess products, product changes, and new technologies with regard to qualification, classification, regulatory pathways, and regulatory requirements • Communicate with notified bodies, authorities, and other stakeholders • Guide clients through complex coordination and consultation processes • Independently take responsibility for consulting projects and ensure their successful completion

🎯 Requirements

• Completed degree, for example in a natural science, technical, medical, or engineering discipline • At least five years of professional experience in Regulatory Affairs for medical devices • Knowledge of the regulatory requirements under the MDR and FDA regulations • Understanding of how software is developed, documented, and regulated • Interest in AI technologies and willingness to explore their application in medical devices and the resulting regulatory issues • Familiarity with ISO 13485, ISO 14971, and IEC 62304 • Fluency in written and spoken German and English • Willingness to travel occasionally for client projects

🏖️ Benefits

• Innovative working environment with plenty of scope for initiative and the freedom to drive change • Great team atmosphere and strong sense of collaboration • Support for and encouragement of your professional and personal development • Flexible working arrangements with no core hours • Remote work or work from our locations in Konstanz or Frankfurt • JobRad bicycle leasing program • Hansefit corporate fitness program • Two team events per year • Opportunity to work from another location for a limited period (workation)