Senior Expert Engineering RMCS

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

, ensuring risks are adequately mitigated and justified.

• Develop and strengthen

(e.g. testing vs. not testing, process controls, verification strategies) across development and lifecycle stages.

• Drive

of Risk Management Files (RMF), Risk Management Plans, and Risk Management Reports across projects and platforms.

• Provide expert guidance to project teams on

.

• Support

, 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

• Advanced degree in engineering, life sciences, or a related technical discipline.
• Fluent English - both spoken and written.
• Extensive hands-on experience in

.

• Strong working knowledge of

, EU MDR, FDA device expectations, and Quality-by-Design principles.

• Proven ability to translate complex technical risks into

.

• 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

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.