Senior Expert Engineering RMCS

Novartis; Österreich; Híbrido; EUR 59.000 - 72.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Market-competitive base salary

Company pension

Childcare facilities

Learning and development opportunities

Worldwide career possibilities

Descripción de la vacante

Novartis in Schechtenau, Austria, seeks a Senior Expert Risk Management & Control Strategy to lead risk identification, assessment and control strategy across the device development lifecycle. You will interface with design, quality, regulatory, manufacturing and suppliers to enable defendable decisions.

This high-impact role combines technical authority with strategic influence, requiring experience with ISO 14971, EU MDR and regulatory submissions.

Formación

• Fluent English in both spoken and written form.
• Extensive hands-on experience in medical device and/or drug-device risk management.
• Strong knowledge of ISO 14971, EU MDR and FDA expectations in quality design.
• Ability to translate complex risks into clear, regulator-ready docs.
• Proven ability to influence cross-functional stakeholders without authority.

Responsabilidades

• Act as senior SME for device risk management per ISO 14971, MDR and FDA expectations.
• Define, assess and challenge technical and use-related risks with justification.
• Develop and strengthen risk control strategies across development and lifecycle.
• Drive consistency of RMFs, RM Plans and RM Reports across projects.
• Provide guidance on risk acceptability and benefit-risk considerations.
• Support health authority submissions and inspection readiness on risk management.
• Contribute to templates, guidance documents and training materials.
• Coach junior experts and strengthen risk management culture.
• Pre-align with stakeholders to avoid late-stage surprises.

Conocimientos

Fluent English

Risk management experience

Regulatory knowledge

Cross-functional influence

Documentation/communication

Educación

Advanced degree in engineering or life sciences

Descripción del empleo

Summary

With the increasing diversity and complexity of Novartis’ drug delivery device and drug‑device combination product portfolio, robust and harmonized risk management and control strategies are critical to ensure patient safety, regulatory compliance, and sustainable product quality.

As Senior Expert Risk Management & Control Strategy, you will act as a technical and strategic authority within the RMCS team, shaping how risks are identified, assessed, controlled, and documented across the device development lifecycle. You will work at the interface of design, quality, regulatory, manufacturing, and suppliers, enabling defendable decisions and fit‑for‑purpose control strategies for global development programs.

This is a high-impact individual contributor role, ideal for an expert who enjoys solving complex problems, influencing without authority, and raising the overall maturity of risk management practices across a portfolio.

About The Role

Location: Schechtenau, Austria

Work Pattern: Hybrid

Please note that this position does not include relocation support. Candidates should therefore already be based in, or able to work from, the advertised location.

Key Responsibilities

• Act as senior subject matter expert for device and combination product risk management in accordance with ISO 14971, MDR, FDA expectations, and Novartis internal standards.
• Define, assess, and challenge technical/design, manufacturing, and use‑related risks, ensuring risks are adequately mitigated and justified.
• Develop and strengthen control strategies (e.g. testing vs. not testing, process controls, verification strategies) across development and lifecycle stages.
• Drive consistency and quality of Risk Management Files (RMF), Risk Management Plans, and Risk Management Reports across projects and platforms.
• Provide expert guidance to project teams on risk acceptability, residual risk justification, and benefit‑risk considerations.
• Support health authority submissions and interactions, including inspection readiness and responses related to risk management and control strategy.
• Contribute to methodologies, templates, guidance documents, and training materials.
• Coach and mentor junior experts and project team members, strengthening risk management capability and culture across the organization.
• Proactively engage stakeholders to pre‑align on risk positions and avoid late‑stage surprises.

Essential Requirements

• Advanced degree in engineering, life sciences, or a related technical discipline.
• Fluent English – both spoken and written.
• Extensive hands‑on experience in medical device and/or drug‑device combination product risk management.
• Strong working knowledge of ISO 14971, EU MDR, FDA device expectations, and Quality‑by‑Design principles.
• Proven ability to translate complex technical risks into clear, defendable, and regulator‑ready documentation.
• Track record of influencing cross‑functional stakeholders without direct authority.
• Structured, analytical mindset with strong judgment and decision‑making capability.

Desirable

• Experience across multiple device platforms (e.g. autoinjectors, inhalers, pumps).
• Exposure to combination products within pharmaceutical development.
• Experience supporting regulatory submissions, audits, or inspections.
• Ability to act as a reference point for best practices and emerging regulatory trends.
• German language is not required but would be an advantage.

Salary & Benefits

In addition to a market‑competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group.

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 €65,504/year (on a full‑time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Accessibility And Accommodation

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [e-mail] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

Learn about all the ways we’ll help you thrive personally and professionally.

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