Auf einen Blick
- Aufgaben: Leite die globale Regulierungsstrategie für innovative Kombinationsprodukte und arbeite eng mit verschiedenen Teams zusammen.
- Unternehmen: Führendes Unternehmen im Bereich digitale Gesundheit und Medizintechnik mit einem Fokus auf Innovation.
- Vorteile: Attraktives Gehalt, flexible Arbeitszeiten, Weiterbildungsmöglichkeiten und ein unterstützendes Team.
- Weitere Informationen: Dynamisches Arbeitsumfeld mit hervorragenden Entwicklungschancen und interdisziplinärer Zusammenarbeit.
- Warum dieser Job: Gestalte die Zukunft der Gesundheitsversorgung und beeinflusse wichtige regulatorische Entscheidungen weltweit.
- Qualifikationen: Mindestens 10 Jahre Erfahrung in der Regulierungsbehörde, idealerweise mit Kombinationsprodukten.
Das prognostizierte Gehalt liegt zwischen 60000 - 78000 € pro Jahr.
Your Role
In this pivotal role, you will own and drive the global regulatory strategy for drug-device combination products, shaping the pathway from early development through to approval and lifecycle management.
You will serve as the Device Regulatory Lead within a cross-functional regulatory strategy team, working in close partnership with CMC, device engineering, and quality colleagues to ensure compliant, timely, and scientifically credible submissions to health authorities worldwide.
Your ability to build trusted relationships with regulatory agencies and to translate complex regulatory requirements into clear, actionable strategies will be central to accelerating the development of innovative combination products.
Operating with considerable autonomy, you will influence both internal decision-making and external regulatory outcomes, contributing to a culture of regulatory excellence and risk-based thinking across the R&D organization.
Who You Are
- Hold a degree in a life science or related discipline (MSc minimum or equivalent); a higher degree such as a Ph D in a scientific discipline is preferred.
- Have 10 or more years of regulatory affairs experience, with proven and recent expertise in drug-device combination product submissions and/or medical devices for US, EU, and international markets.
- Have a demonstrated ability to develop global regulatory strategies and assemble dossiers for submissions including EU MAA, NBOp, CTA, US IND, NDA, BLA for combination products, 510(k), and PMA; international experience is strongly preferred.
- Have a proven track record of productive collaboration with regulatory authorities through scientific advice meetings, and act as a credible, influential spokesperson during such interactions.
- Possess a solid understanding of the drug-device combination and medical device regulatory framework across EU, US, and international markets, including ICH, EU-MDR, MDSAP, ISO 13485, c GMP for combination products, QMS, technical file requirements, e CTD, and MCDG guidelines.
- Prior experience with regulatory CMC and connected drug-device combination products for medicinal products is an advantage.
- Are a strong team player who thrives in a highly multidisciplinary environment and communicate effectively with colleagues and stakeholders from diverse professional backgrounds.
- Are fluent in English; proficiency in additional languages is an asset.
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Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender) Arbeitgeber: Merck KGaA
Merck KGaA bietet eine dynamische und unterstützende Arbeitsumgebung in Aubonne, Schweiz, wo Innovation und Teamarbeit im Mittelpunkt stehen. Als Arbeitgeber fördern wir das Wachstum unserer Mitarbeiter durch kontinuierliche Weiterbildung und spannende Projekte im Bereich der biopharmazeutischen Produkte. Profitieren Sie von einer attraktiven Work-Life-Balance und der Möglichkeit, an der Spitze der Technologieentwicklung zu arbeiten.
