Employee in Quality Management And/or Regulatory Affairs

vor 14 Stunden

Salzburg, Österreich medPhoton GmbH Vollzeit

**Company Description**
medPhoton is one of the most innovative companies in Salzburg. Our medical imaging solutions and products stand for the highest quality and are available at medical facilities worldwide. We develop cutting edge medical devices and corresponding software, on our Salzburg premises.

As a professional QM/RA associate, you will be responsible for the following tasks:

- Support and collaborate across all areas of **Quality Management (QM)**.
- Ongoing control, improvement, and optimization of **quality management processes** and standards.
- Assist in creating and reviewing **deviation reports, risk management plans, and CAPA** (Corrective and Preventive Actions), ensuring thorough monitoring of corrective actions.
- Ensure the **implementation and monitoring of regulatory requirements** for medical devices.
- ** Assist with international product certifications** and approvals.
- ** Liaise with regulatory bodies** and authorities, including correspondence with notified bodies (globally).
- ** Support clinical evaluations**, ensuring that medical devices meet clinical safety and performance requirements in accordance with regulatory standards.
- Participate in **post-market surveillance activities**, including monitoring product performance in the market and managing feedback loops to continuously improve device safety and effectiveness.
- Support **internal and external audits** as well as supplier audits.
- Assist R&D with **documentation** and support the development process.

**Qualifications**
- Experience or training in **Quality Management**, preferably in the **medical device sector** (ISO 13485) or any industry with high regulatory standards.
- Knowledge of **EU MDR** (Medical Device Regulation) and experience with Class II or higher medical devices is an advantage.
- Familiarity with **clinical evaluations** and **post-market surveillance** processes under MDR guidelines is highly desirable.
- Knowledge of **international regulations and certifications** for medical devices is a plus.
- ** Fluent in German and English** (written and spoken).
- Flexible, team-oriented, and eager to work in an **international environment**.
- We also encourage _**_recent graduates_**_ or _**_career changers_**_ who are eager to learn and develop in the field of Quality Management and Regulatory Affairs._
**Additional Information**
WHAT WE OFFER YOU
- A motivating work atmosphere in a young, dynamic team
- An exciting and varied scope of assignments customized for your skills and interests (e.g. backend services, medical format networking, databases, robotic kinematics, image processing, geometry / visualization, UI/UX...)
- The opportunity to grow with us, be directly involved and participate in our company’s success
- A secure, permanent full-time contract
- Generous social benefits within our culturally diverse enterprise - consisting of 19 nations
- Freshly-cooked meals and healthy snacks provided daily
- Good public transport connections and parking facilities (for both, four and two wheels) available
- As a family-friendly company, we are happy to support you in your daily obligations (childcare, etc.) by means of flexible working hours.

As a family-friendly company, we are happy to support you in your daily obligations (childcare, personal education etc.) by offering flexible working hours. We are also happy to welcome people returning to work and career starters

  • Career Starter: Quality Management

    vor 14 Stunden

    Salzburg, Österreich medPhoton Vollzeit

    Join us in the future-oriented industry of medical technology and help us to establish and maintain a quality management system that will enable us achieve our goals, especially regarding customer satisfaction (including patient safety), as well as to quickly and safely obtain international approval for our innovative medical devices and to master regulatory...

  • Experte/expertin Regulatory Affairs International

    vor 7 Monaten

    Salzburg, Österreich BIOGENA GROUP Vollzeit

    **Experte/Expertin Regulatory Affairs International (m/w/d) für den Bereich Lebensmittelrecht/Nahrungsergänzungsmittel**:** **STANDORT*** **Salzburg oder Wien** ***ARBEITSZEIT*** **Vollzeit** *** **Welcome to Yourself**: Wir bei BIOGENA haben ein großes Ziel: Mehr Gesundheit & Wohlbefinden für möglichst viele Menschen auf dieser Welt. Nach dem Motto...

  • Experte/expertin Regulatory Affairs International

    vor 3 Wochen

    Salzburg, Österreich BIOGENA GROUP Vollzeit

    WIR SUCHEN **Experte/Expertin Regulatory Affairs International (m/w/d) für den Bereich Lebensmittelrecht/Nahrungsergänzungsmittel**: **Welcome to Yourself**: - Wir bei BIOGENA haben ein großes Ziel: Mehr Gesundheit & Wohlbefinden für möglichst viele Menschen auf dieser Welt. Nach dem Motto „Welcome to yourself“ gehen wir mit jeder Menge...

  • Experte/expertin Regulatory Affairs International

    vor 4 Wochen

    Salzburg, Österreich Biogena Naturprodukte GmbH Vollzeit

    **Welcome to Yourself**: - Wir bei BIOGENA haben ein großes Ziel: Mehr Gesundheit & Wohlbefinden für möglichst viele Menschen auf dieser Welt. Nach dem Motto „Welcome to yourself“ gehen wir mit jeder Menge Leidenschaft die Extrameile zur vollen Potenzialentfaltung und begeistern damit jeden Tag mehr Menschen, die selbst Verantwortung für ihre...

  • Expert Legal Affairs

    vor 7 Monaten

    Salzburg, Österreich BMW Group Salzburg Vollzeit

    Expert Legal Affairs - Austria & Central and Southeastern Europe - With its brands BMW, MINI and Rolls-Royce the BMW Group is one of the world’s most successful premium manufacturers of automobiles and motorcycles as well as a provider of premium services for individual mobility. The engine for the intensity and attraction of our products and services is...

  • Experte/in (M/w/d) Produktentwicklung & Regulatory

    vor 7 Monaten

    Salzburg, Österreich Biogena Naturprodukte GmbH Vollzeit

    **Was es hier zu tun gibt**: PRODUKTENTWICKLUNG: - Begleitung und eigenständige Übernahme (nach Onboarding) von Produktentwicklungs-Prozessen in Abstimmung mit der Leitung von der Produktentwicklung: Literatur - und Marktrecherchen, Safety-Check, Erstellung und Kalkulation von Rezepturen, Abstimmung mit den Abteilungen Einkauf und Produktion - Prüfung...

  • Mitarbeiter/in Qualitätsmanagement

    Vor 6 Tagen

    Salzburg, Österreich medPhoton Vollzeit

    medPhoton ist eines der innovativsten Unternehmen im Bundesland Salzburg. Unsere Bildgebungslösungen in der Medizintechnik und unsere Produkte stehen für absolute Qualität und sind weltweit in führenden Kliniken im Einsatz. Wir entwickeln nicht nur die Software, sondern fertigen auch die dazugehörigen Geräte selbst hier vor Ort. Für unsere...

  • Head Quality Management

    vor 1 Woche

    Salzburg, Österreich Procomcure Biotech Vollzeit

    Procomcure Biotech GmbHWir sind eine wachsende biotechnologie Firma mit Sitz in Thalgau und suchen derzeit 1 Head Quality Management für die Herstellung von in-vitro Diagnostik ProduktenVOLLZEITHauptaufgaben: *Leitung des Qualitätsmanagements in einem bereits ISO 9001 und 13485 zertifizierten Betrieb*Weiterentwicklung der bereits vorhanden...

  • Regulatory Compliance Specialist for Beverage Innovation

    vor 3 Wochen

    Salzburg, Salzburg, Österreich Red Bull Vollzeit

    We are seeking an experienced Regulatory Compliance Specialist to join our team in Fuschl, Austria. Located at the international Red Bull Headquarter, this role will play a crucial part in strengthening our Beverage Innovation Department.The ideal candidate will have a strong background in regulatory compliance and food science, with excellent communication...

  • Quality Manager

    vor 14 Stunden

    Salzburg, Österreich Klüber Lubrication Austria Ges.m.b.H. Vollzeit

    Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. Klüber Lubrication, a...

  • Lead Product Information Management

    vor 7 Monaten

    Salzburg, Österreich KTM Group Vollzeit

    **THE OPPORTUNITIES ARE ENDLESS WHEN YOU ARE FEARLESS**: Driven by the passion of over 6000 employees, KTM AG is the largest European motorcycle manufacturer with a revenue of over €2 billion. To this end, we consistently pursue a long-term strategy based on the four pillars of brand, globalization, innovation and employees. That’s why we are looking for...

  • Risk Management Specialist for Compliance

    vor 4 Wochen

    Salzburg, Salzburg, Österreich ALDI Vollzeit

    About the RoleWe are seeking a highly skilled Risk Management Specialist to join our compliance team. In this role, you will be responsible for conducting comprehensive risk assessments and implementing effective mitigation strategies.Key ResponsibilitiesDevelop and maintain a thorough understanding of globally recognized risk management standards,...

  • ESG Risk Management Specialist

    vor 1 Monat

    Salzburg, Salzburg, Österreich ALDI Vollzeit

    Join a Global Compliance and Risk OrganizationWe are seeking an experienced ESG Risk Management Expert to join our global compliance and risk organization.About the RoleIn this role, you will be responsible for integrating ESG risk management into our risk management system, focusing on risk assessments and mitigations. You will consolidate existing data and...

  • Lead Quality Manager Product Line Aerial Work Platforms

    vor 1 Monat

    Salzburg, Salzburg, Österreich PALFINGER AG Vollzeit

    Company OverviewPALFINGER AG, a global technology and engineering company, has been lifting people and goods to new heights for over 90 years with its pioneering and passionate spirit.We are the world's leading manufacturer and supplier of innovative crane and lifting solutions. Our success is built on the tireless efforts of approximately 12,700 employees...

  • ESG Risk Management Expert

    vor 1 Monat

    salzburg, Österreich ALDI Vollzeit

    How You’ll Make Your MarkYour main tasks in this role are: In this role, you will be responsible for ESG risk management which has to be integrated into our risk management system with focus on risk assessments and mitigationsYou will consolidate existing data and risk assessments to enhance our risk management system by followingglobally acknowledged...

  • ESG Risk Management Expert

    vor 3 Wochen

    salzburg, Österreich ALDI Vollzeit

    How You’ll Make Your MarkYour main tasks in this role are: In this role, you will be responsible for ESG risk management which has to be integrated into our risk management system with focus on risk assessments and mitigationsYou will consolidate existing data and risk assessments to enhance our risk management system by followingglobally acknowledged...

  • Global Supply Chain Management Expert

    vor 2 Monaten

    Salzburg, Salzburg, Österreich ALDI Vollzeit

    We are seeking a highly skilled Global Supply Chain Management Expert to join our team in Wals, Austria. As a key member of our international supply chain management department, you will play a critical role in ensuring the smooth operation of our global logistics network.Your primary responsibilities will include:Researching and analyzing relevant topics...

  • ESG Risk Management Expert

    vor 2 Wochen

    Salzburg, Salzburg, Österreich ALDI SÜD HOLDING Vollzeit

    MAKE YOUR MARK ESG Risk Management Expert (f/m/d) How You'll Make Your Mark Your main tasks in this role are: * In this role, you will be responsible for ESG risk management which has to be integrated into our risk management system with focus on risk assessments and mitigations * You will consolidate existing data and risk assessments to enhance our...

  • Haustechniker:in Elektro Technisches Facility Management

    vor 1 Monat

    Salzburg, Österreich STRABAG Property and Facility Services GmbH Vollzeit

    Bei STRABAG bauen rund 86.000 Menschen an 2.400 Standorten weltweit am Fortschritt. Einzigartigkeit und individuelle Stärken kennzeichnen dabei nicht nur unsere Projekte, sondern auch jede:n Einzelne:n von uns. Ob im Hoch- und Ingenieurbau, Straßen- und Tiefbau, Brücken- und Tunnelbau, in der Projektentwicklung, Baustoffproduktion oder im...

  • Quality Research Manager:in

    Vor 5 Tagen

    Salzburg, Österreich SES Spar European Shopping Centers GmbH Vollzeit

    **Vollzeit**SES Salzburg (Österreich)** **QUALITY RESEARCH MANAGER:IN**: **Ihre Aufgaben**: - **Qualitätsmanagement**: Sie führen die Qualitätskontrollen in unseren Shopping-Centern durch und dokumentieren die Ergebnisse. - **Weiterentwicklung**: Sie sorgen für eine kontinuierliche Optimierung und Verbesserung der Qualitätssicherung in unseren...