Fresenius Kabi SwissBioSim GmbH
Senior Manager Regulatory Affairs Lead(m/w/x)
Vollzeitnur vor OrtSenior
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SUSUSONITY
Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products(m/w/x)
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Global regulatory strategy for drug-device combination products, shaping development pathways and managing lifecycles. 10+ years regulatory affairs experience with recent combination product submission expertise required. Device Regulatory Lead role in cross-functional teams, collaborating with CMC, engineering, and quality.
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Anforderungen
- Degree in life science or related discipline (MSc minimum or equivalent); PhD preferred
- 10+ years regulatory affairs experience
- Proven, recent expertise in drug-device combination product submissions
- Proven, recent expertise in medical devices for US, EU, international markets
- Demonstrated ability to develop global regulatory strategies
- Assemble dossiers for submissions (EU MAA, NBOp, CTA, US IND, NDA, BLA, 510(k), PMA)
- International experience strongly preferred
- Proven track record of productive collaboration with regulatory authorities
- Able to act as credible, influential spokesperson during interactions
- Solid understanding of drug-device combination regulatory framework (EU, US, international)
- Solid understanding of medical device regulatory framework (EU, US, international)
- Knowledge of ICH, EU-MDR, MDSAP, ISO 13485, cGMP, QMS, technical file requirements, eCTD, MCDG guidelines
- Prior experience with regulatory CMC for combination products is an advantage
- Prior experience with connected drug-device combination products for medicinal products is an advantage
- Strong team player
- Thrives in multidisciplinary environment
- Effective communication with colleagues and stakeholders
- Fluent in English
- Proficiency in additional languages is an asset
Aufgaben
- Drive global regulatory strategy for drug-device combination products
- Shape development pathway from early stages to approval
- Manage lifecycle of combination products
- Serve as Device Regulatory Lead in cross-functional team
- Collaborate with CMC, device engineering, and quality teams
- Ensure compliant and timely submissions to health authorities
- Build trusted relationships with regulatory agencies
- Translate complex regulatory requirements into actionable strategies
- Accelerate development of innovative combination products
- Influence internal and external regulatory decisions
- Promote culture of regulatory excellence and risk-based thinking
Berufserfahrung
10 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – fließend
other – Grundkenntnisse
Tools & Technologien
EU MAANBOpCTAUS INDNDABLA510(k)PMAICHEU-MDRMDSAPISO 13485cGMPQMSeCTD
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