Device Project Lead
vor 14 Stunden
**Your Key Responsibilities**:
Your responsibilities include, but are not limited to:
- Project leadership (planning, coordination, specifications, risk management, documentation, design transfer)
- Development oversight including detail design; ergonomics and usability (including HF/UE documentation); lead design reviews
- Creation and management of Design History Files and associated documentation for selected combination products per the annual plan and objectives, and relevant standards and guidelines e.g. ISO13485, 21 CFR Part 820.30, 21 CFR 3.2(e). etc.
- Lead, represent, and manage cross-functional device project teams.
- Management of activities following project strategies, budget, timelines, regulatory, quality, and professional standards.
- Enabling operational excellence in compliance with the current and anticipated professional trends
- Performing activities in compliance with Good Manufacturing Practices
- Ensuring inspection readiness.
**What you’ll bring to the role**:
**Essential Requirements**:
- Work experience with combination products (or device constituent parts thereof) or standalone medical devices development.
- Knowledge of GMP and international device regulations;
- Knowledge of regulatory/QA requirements for medical devices/combination products
- Ability to communicate and collaborate effectively in a highly international and diverse setting;
- Digital excellence and automation of documentation management.
- Track record of goal-driven behaviour, problem-solving, ability to make pragmatic decisions, and readiness for new challenges
- Fluency in English
**You´ll receive**:
- Attractive salary with incentive program
- Modern company pension scheme
- Flexible working hours / home-office depending on the position
- 14 weeks of paid parental leave
- Additional days off (bridge-days)
- Subsidized meals in our canteen
- Sustainable mobility in the form of company transportation, shift buses and car sharing
- Company Kindergarden and summer camps for children
- Wellbeing & mental health offers
- Learning and development options for your personal and professional growth
- Worldwide career opportunities
In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 64.023,54/year (on a full-time basis).
In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
**Why Sandoz?**
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
**Commitment to Diversity & Inclusion**:
We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.
**Join our Sandoz Network**:If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here**:Sandoz Talent Pool**
**#Sandoz**
null
null
-
Medical Device Expert
Vor 6 Tagen
Kundl, Tirol, Österreich Sandoz Österreich VollzeitJob DescriptionMedical Device Expert (d/f/m) | Kundl, AustriaSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is...
-
QA Medical Device Expert
vor 1 Woche
Kundl, Tirol, Österreich Sandoz Österreich Vollzeit € 65.005 - € 120.000 pro JahrJob DescriptionQA Medical Device Expert (d/f/m) | Kundl, AustriaSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future...
-
Medical Device Expert
Vor 6 Tagen
Kundl, T, Österreich Sandoz VollzeitMedical Device Expert (d/f/m) | Kundl, AustriaSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to...
-
QA Medical Device Expert
vor 1 Woche
Kundl (Sandoz), Österreich Sandoz Vollzeit € 65.505 - € 100.000 pro JahrJob Description SummaryQA Medical Device Expert (d/f/m) | Kundl, AustriaJob DescriptionQA Medical Device Expert (d/f/m) | Kundl, AustriaSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique...
-
Kundl, Österreich TECCON Consulting & Engineering GmbH VollzeitVollzeit |Kundl- Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the...
-
Kundl, Tirol, Österreich TECCON Consulting GmbH Vollzeit € 80.000 - € 120.000 pro JahrVollzeit | KundlAre you an expert in your field, ready to apply your know-how to exciting projects?Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between...
-
Kundl, T, Österreich TECCON Consulting & Engineering GmbH Vollzeit € 90.000 - € 120.000 pro JahrVollzeit |KundlAre you an expert in your field, ready to apply your know-how to exciting projects?Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between...
-
Project Manager
vor 1 Woche
Kundl, Österreich Emerson VollzeitWe are looking for a high-performing and experienced Project Manager (M/F/d) to take on a key position within our Systems and Software business unit and who will have the overall responsibility and authority for the implementation and execution of customer’s projects, mainly within the Life Science Industry. Are you a strong leader with excellent social...
-
Project Manager
vor 1 Woche
Kundl, Österreich Sandoz Vollzeit**Project Manager (f/m/d), Sandoz Development Center, Kundl, Austria** 50! The number of projects managed by this international and diverse project management team. As a project manager you will lead teams across the globe and bring products to life. With the full end-to-end responsibility for your portfolio you will have a big footprint in Sandoz' strategy...
-
Kundl, Tirol, Österreich Planet Pharma Vollzeit € 60.000 - € 80.000 pro JahrWe're Hiring: Legal & Compliance Project Manager (SAP/ERP Focus) Location: Hybrid Kundl | Language: English & GermanAre you passionate about driving global compliance initiatives and leading impactful projects in a dynamic environment? We're looking for aLegal and Compliance Project Managerto support and enable key programs that align with our business...
