Senior Regulatory Affairs Specialist
4 days ago
TFS HealthScience är en ledande globala Contract Research Organization (CRO) som stöttar bioteknik- och läkemedelsföretag genom hela kliniska utvecklingsresan. Vår expertis omfattar kompletta tjänster, strategisk resursförsörjning och funktionella tjänstelösningar (FSP), vilket gör oss till en pålitlig partner för framgångsrika kliniska projekt.
Som medlem i vårt dedikerade SRS/FSP-team kommer du att arbeta nära en av våra sponsorer inom medicinteknik och ge dem stöd genom din specialistkunskap.
Många av sponsorns produkter och tjänster omfattas av krav inom nationella medicinska informationssystem (HSLF 2022:42) och medicintekniska regelverket MDR. För att uppfylla dessa regelverk behöver sponsorn genomföra kliniska utvärderingar för att säkerställa produkternas säkerhet, prestanda och kliniska nytta. Därför söker vi nu en senior konsult med gedigen erfarenhet av kliniska utvärderingar och djupgående kunskap om aktuella regelverk, som kan tillföra kvalificerad vägledning och rådgivning under en tidsbegränsad period.
Utbildning, processförbättring och vägledning
- Utbilda personal inom regelverk, standarder och riktlinjer för kliniska utvärderingar.
- Processförbättring: Analysera och optimera rutiner och processer för att säkerställa regulatorisk efterlevnad och effektivitet.
- Vägledning till utvärderingsteam:
- Planering: Säkerställ att utvärderingsplaner (CEP) uppfyller krav på riskhantering och datainsamling.
- Datakällor: Identifiera och validera kliniska studier, vetenskaplig litteratur och RWD (real-world data).
- Litteraturstudier: Utför och vägled systematiska litteraturstudier enligt MEDDEV 2.7/1 rev 4.
- Granskning: Ge konstruktiv feedback på genomförda utvärderingar för att säkerställa regulatoriska krav och kvalitetsstandarder uppfylls.
Kravprofil
- Erfarenhet: Minst 5 års erfarenhet av kliniska utvärderingar och kliniska prövningar enligt MDR 2017/745, ISO 14155 samt relaterade riktlinjer.
- Expertis inom medicinteknisk mjukvara (SaMD): Erfarenhet av medicintekniska produkter inom klass IIa eller högre, enligt MDR 2017/745.
- Nationella medicinska informationssystem: Dokumenterad erfarenhet av HSLF 2022:42 och LVFS 2014:7.
- Språkkunskaper: Flytande svenska och engelska, både i tal och skrift.
Bonus och lön
Vi erbjuder en mycket attraktiv bonus och lönen, cirka **550 000**–**650 000** kronor per år beroende på erfarenhet och placering. I den här rollen kommer du att få möjlighet att utvecklas och växa inom en positiv och dynamisk miljö.
Kontaktinfo
Vill du veta mer om jobbet? Kontakta oss via telefon eller mejl för att diskutera dina framtida karriärmöjligheter.
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