Our client is a family-owned start-up company with its headquarters in Vienna. The spin-off company of the Medical University of Vienna (MUV) was founded in January 2017. They are searching for applicants who wants to make a sustainable contribution to their success to develop and market a novel test for the non-invasive early detection of ovarian cancer and its prestages.
Currently we are looking for a
medical products, ISO13485, MDR
You will play a crucial role in the product development and certification process. Moreover, you will also support the regulatory strategy and implement the Quality Management System (ISO 13485, MDR) for further certification. You will work in a dynamic and experienced team on demanding and responsible solutions. At the beginning, you will be supported by an external consultant to get everything in place soon.
Responsibility & Tasks
Establish and maintain Quality Management System according to ISO 13485 and MDR including review of QMS
documents and records. Ensure the conformity of medical devices in accordance with the QM system
Coordinate and oversee risk management activities and provide support for planning and supervising clinical trials in compliance with ISO 14155
- Lead our medical device and in vitro diagnostics certification process and oversee the continuous compliance for medical devices, in vitro diagnostics and medical software (MDR, IVDR)
Support our team in the certification process as well as defining and updating the regulatory framework for MDR/IVDR
products. Ensuring that market surveillance is carried out in accordance with EU directives and reporting obligations are fulfilled in accordance with the EU Directives
Analyze and interpret international laws, ordinances, standards and for medical device manufacturers and independently derive the resulting regulatory requirements for our product. Communicate and align with external stakeholders.
At least one year of professional experience in quality management or regulatory affairs. This work experience
should be related to medical devices.
Experience with clinical development and regulatory filings as well as with certification of MD/IVD and/or related software solutions
Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Austrian regulatory authorities landscape as well as sound knowledge of international laws, standards and regulations for licensing medical devices, and of the business processes of medical device manufacturers (e.g. MDD & MDR, ISO 13485; IEC 62366; ISO 14971, ISO 14155, ISO
Demonstrate high level of organization, multi-tasking, judgement and analytical skills. Good time management skills to ensure adherence to timelines
- Excellent Language Skills in both languages German and English
Attractive Working Conditions
Our client facilitate position-specific training & development in the filed of Regulatory Affairs, so that you can grow together in the long term.
They offer varied work in a rapidly expanding company as well as flexible working hours together with a high part of remote work, if desired.
Annual gross salary of at least € 52,500 p.a. on a full-time basis. Depending on qualifications and experience, they are willing to adjust the salary.
If you want to become part of a dynamic team, we look forward to meeting you! If you are interested and you believe you are the right person to join the team, please send us your job application including your CV, references and compensation expectations to Roman Spicl via E-Mail email@example.com or directy via the „Bewerben“ button below.
Referenznummer 65-164385 bewerben
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