Device Expert - Risk Management (m/f)

Area of Responsibility
Device Expert - Risk Management (m/f), Device Development & Commercialization, Schaftenau, Austria

74! The number of medical device projects in Novartis. Without a safe, user friendly, high-quality drug delivery system our patients cannot take their medicine. Device Risk Management in Schaftenau needs you to realise one of the most diverse and innovative medical device portfolios in the pharma industry. We ensure that all risks which come with the use of the device are identified and under control.

Your Responsibilities:

Your responsibilities include, but are not limited to:
• Ensure timely completion and quality of the assigned risk management files
• Lead specific risk management activities within projects, as agreed with project leaders
• Ensure compliance with ISO 14971 in all development projects assigned
• Conduct and provide guidance on the use of risk analysis for use, products, components and processes
• Guide internal and external functions on creating, reviewing and approving medical device risk management files
• Author the documentation in the medical device risk management file

Qualification
What you’ll bring to the role:
• University degree or University of Applied Sciences degree (Mechanical Engineering, Biotechnology, Biomedical Engineering, Medical Technology) or similar education
• Minimum 3 years of relevant experience within risk management
• General understanding of medical devices
• Good moderation, communication and technical writing skills
• Languages: English (fluent) / German beneficial

Desirable requirements:
Experience in risk management activities for combination products beneficial

Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of the respective amount according to the Austrian collective agreement (at least € 45,792.46 per year on a full time basis), plus a potential market oriented excess payment.

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Tel. 05338/200-0
www.novartis.at