Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Human Factors Engineering(m/w/x)
Vollzeitnur vor OrtSenior
Schaftenau
ab 65.605,54 / Jahr
Neuer Job?Nejo!
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NONovartis Pharmaceutical Manufacturing GmbH
Senior Expert Risk Management & Control Strategy(m/w/x)
Schaftenau
ab 65.604,54 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Expert risk management for medical devices and combination products, defining and assessing technical, design, and use-related risks. Extensive hands-on experience with ISO 14971 and EU MDR required. Focus on clear, regulator-ready documentation and influencing cross-functional stakeholders.
Anforderungen
- Advanced degree in engineering, life sciences, or related technical discipline
- 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, regulator-ready documentation
- Track record of influencing cross-functional stakeholders without direct authority
- Structured, analytical mindset with strong judgment and decision-making capability
- 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 reference point for best practices and emerging regulatory trends
Aufgaben
- Act as senior subject matter expert for device and combination product risk management
- Define, assess, and challenge technical, design, manufacturing, and use-related risks
- Develop and strengthen control strategies across development and lifecycle stages
- Drive consistency and quality of Risk Management Files, Plans, and Reports
- Provide expert guidance on risk acceptability, residual risk justification, and benefit-risk considerations
- Support health authority submissions and interactions, including inspection readiness and responses
- Contribute to methodologies, templates, guidance documents, and training materials
- Coach and mentor junior experts and project team members
- Proactively engage stakeholders to pre-align on risk positions and avoid late-stage surprises
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – fließend
Tools & Technologien
- ISO 14971
- EU MDR
- FDA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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NONovartis Pharmaceutical Manufacturing GmbH
Senior Expert Risk Management & Control Strategy(m/w/x)
Schaftenau
ab 65.604,54 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Expert risk management for medical devices and combination products, defining and assessing technical, design, and use-related risks. Extensive hands-on experience with ISO 14971 and EU MDR required. Focus on clear, regulator-ready documentation and influencing cross-functional stakeholders.
Anforderungen
- Advanced degree in engineering, life sciences, or related technical discipline
- 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, regulator-ready documentation
- Track record of influencing cross-functional stakeholders without direct authority
- Structured, analytical mindset with strong judgment and decision-making capability
- 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 reference point for best practices and emerging regulatory trends
Aufgaben
- Act as senior subject matter expert for device and combination product risk management
- Define, assess, and challenge technical, design, manufacturing, and use-related risks
- Develop and strengthen control strategies across development and lifecycle stages
- Drive consistency and quality of Risk Management Files, Plans, and Reports
- Provide expert guidance on risk acceptability, residual risk justification, and benefit-risk considerations
- Support health authority submissions and interactions, including inspection readiness and responses
- Contribute to methodologies, templates, guidance documents, and training materials
- Coach and mentor junior experts and project team members
- Proactively engage stakeholders to pre-align on risk positions and avoid late-stage surprises
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – fließend
Tools & Technologien
- ISO 14971
- EU MDR
- FDA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Novartis Pharmaceutical Manufacturing GmbH
Branche
Pharmaceuticals
Beschreibung
The company aims to reimagine medicine to improve and extend people's lives.
Noch nicht perfekt?
- Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Human Factors Engineering(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert Science & Technology (Process Analytical Sciences)(m/w/x)
Vollzeitnur vor OrtManagementSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Expert Human Factors Engineering(m/w/x)
Vollzeitnur vor OrtKeine AngabeSchaftenauab 59.781,96 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior Expert DSP Development(m/w/x)
Vollzeitnur vor OrtSeniorSchaftenauab 59.781,96 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Quality Manager Pilot Plant(m/w/x)
Vollzeitnur vor OrtManagementSchaftenauab 65.605,54 / Jahr