About EMTensor EMTensor develops an cutting-edge medical imaging device classified as a Class IIb medical device. Our engineering-driven team works at the intersection of physics, electronics, simulation and clinical application to bring advanced imaging closer to the patient.

We are now establishing our Quality Management System from the ground up and are seeking an experienced professional who will shape it, not merely maintain it.

The Role

As QMS & Regulatory Specialist, you will take hands-on ownership of our Quality Management System and technical documentation. Working closely with our engineering team and external regulatory experts, you will translate the defined regulatory strategy into processes and documentation that function effectively in day-to-day engineering practice.

We are looking for an engineer at heart: a professional who understands how a medical device is designed, built and tested, and who develops quality processes that enable engineering rather than impede it.

Key Responsibilities

- Establish and implement a QMS compliant with ISO 13485, based on the completed gap analysis and regulatory strategy
- Prepare and maintain the technical documentation for a Class IIb device under MDR (EU 2017/745)
- Define and operate design control processes, including design inputs and outputs, design reviews, verification and validation, and traceability
- Lead risk management activities in accordance with ISO 14971 in close collaboration with the engineering team
- Implement processes for document control, change management, CAPA and supplier qualification
- Serve as the primary interface between engineering, external consultants and, in due course, the Notified Body




- Prepare the organisation for certification audits

Requirements

- Degree in engineering, physics, biomedical engineering or a related technical discipline
- Minimum of 7 years of professional experience in quality management and/or regulatory affairs for medical devices (ISO 13485, MDR, ISO 14971)
- Proven experience with active medical devices comprising both hardware and software, including IEC 60601 (electrical safety and EMC) and IEC 62304 (software life cycle processes)
- Strong engineering mindset: you work confidently with schematics, test reports, software specifications and design documentation, and ask the right technical questions
- Structured and pragmatic approach, with the ability to design processes suited to a growing technology company
- High degree of independence and ownership in building a function from the ground up
- Fluency in English; German is an advantage

Preferred Qualifications

- Experience leading an organization through its initial ISO 13485 certification
- Hands-on experience in compiling technical files for Class IIa/IIb devices
- Knowledge of cybersecurity requirements for medical device software (IEC 81001-5-1)

How to Apply Please submit your CV together with a cover letter to [email protected]. In your cover letter, please describe:

- The medical devices you have worked on, including device type, risk class and hardware/software scope
- The key regulatory and quality challenges you encountered in bringing these devices into compliance
- How you addressed these challenges and what your personal contribution was

Please note that applications without a cover letter will not be considered. Location: Vienna, Austria

Employment: Full-time

📌 QMS & Regulatory Specialist – Medical Devices (Bengaluru)
🏢 EMTensor
📍 Bengaluru