Senior Expert Engineering RMCS

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Österreich; Hybrid; EUR 59,000 - 72,000; Full time

Benefits offered by this job

Modern pension scheme

Childcare facilities

Learning and development opportunities

Worldwide career possibilities within—

Job summary

Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria, seeks a Senior Expert Risk Management & Control Strategy to lead risk management across device and drug–device programs. You will shape risk identification, assessment, and control strategies across lifecycles, interfacing with design, quality, regulatory, manufacturing and suppliers.

You will act as a technical and strategic authority, coaching teams, ensuring regulator-ready documentation, and driving maturity of RM practices

Qualifications

• 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 risk management.
• Strong knowledge of ISO 14971, EU MDR, FDA device expectations, and QbD principles.
• Proven ability to translate complex risks into regulator-ready documentation.

Responsibilities

• Act as senior subject matter expert for device and combination product risk management per ISO 14971, MDR and FDA expectations.
• Define, assess, and challenge risks across design, manufacturing, and use; justify mitigations.
• Develop and strengthen control strategies across development and lifecycle stages.
• Drive consistency of Risk Management Files, Plans and Reports across projects.
• Provide guidance on risk acceptability, residual risk, and benefit–risk considerations.

Skills

Risk management

Regulatory interpretation

Analytical mindset

Education

Advanced degree in engineering or life sciences

Job description

Salary Range: €66,918.00 - €117,800.00

Job Description 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.

Job Description Location: Schaftenau, 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.

Skills Desired

Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model

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