Regulatory Affairs Specialist

4 weeks ago

Helsingborg, Skåne, Sweden Bioglan Full time
Om tjänsten

Vi söker en erfaren Regulatory Affairs medarbetare som vill vara med och utveckla vår avdelning för Regulatory Affairs och Pharmacovigilance. Som Regulatory Affairs Specialist kommer du att arbeta med life cycle management, nyregistreringar och post market surveillance för medicintekniska produkter.

Dina arbetsuppgifter kommer att inkludera:

  • Ansvara för life cycle management och nyregistreringar för läkemedel i nationell procedur och i DCP/MRP.
  • Ansvara för post market surveillance för medicintekniska produkter.
  • Ge regulatorisk support inom företaget samt till våra kunder/distributörer.
  • Vara projektledare för regulatoriska projekt, och se till att tidsplaner följs.
  • Ansvara för den tekniska filen för våra medicintekniska produkter.
  • Granska och godkänna märkningsmaterial och marknadsföringsmaterial.
  • Utveckla, granska och implementera interna processer.

Arbetsuppgifternas svårighetsgrad styrs av hur erfaren du är inom Regulatory Affairs. Har du flera års erfarenhet kommer du att ha ett större ansvar, och jobba självständigt, jämfört med om du är ny inom Regulatory Affairs.

Din profil

Vi söker en person som har god förmåga att granska en frågeställning ur flera perspektiv och som kan förklara ett komplext regelverk på ett enkelt sätt. Du bör vara noggrann och ha ett strukturerat arbetssätt, men fastna inte i detaljer och trivas att jobba med positiva, hjälpsamma och kompetenta kollegor. Du bör också ha en god förståelse för life cycle management via nationell procedur och DCP/MRP inom EU.

Det är ett krav att du:

  • Har akademisk utbildning inom Life Science.
  • Behärskar svenska och engelska flytande i tal och skrift.

Det är en fördel om du har:

  • 2-3 års erfarenhet av att jobba med life cycle management och nyproduktregistreringar via både DCP/MRP och nationella procedurer.
  • God språklig kompetens i något annat av de nordiska språken.
  • Erfarenhet av att jobba i elektroniska dokumenthanteringssystem.
Vi erbjuder

På Bioglan erbjuder vi en arbetsplats där gemenskap och stöttning står i centrum. Vi strävar efter att bygga starka relationer så att du känner dig som en del av vårt team. Här finns alltid möjligheter att skapa fina minnen tillsammans oavsett om det är under arbetsdagen, under en avkopplande fikapaus eller vid roliga aktiviteter utanför arbetstid.

Vi värdesätter din utveckling och erbjuder dig inte bara ett jobb, utan också en plattform för att växa och utvecklas i din karriär. Vår öppna och positiva arbetsmiljö präglas av god kommunikation, respekt och stödjande kollegor, vilket gör Bioglan till en arbetsplats där du kan trivas. Hos oss är din arbetsglädje och ditt välbefinnande lika viktigt som ditt professionella engagemang, och vi är stolta över att kunna erbjuda en varm atmosfär där du kan vara dig själv.

Bioglan är centralt beläget i Malmö hamn med gratis parkering. Vi erbjuder förmånspaket inklusive friskvårdsbidrag, gratis frukost och frukt dagligen, möjlighet till förmånscykel. Vi tillämpar flexibel arbetstid, och erbjuder ledighet dagarna mellan jul och nyår samt kortare arbetsdag dag före röd helgdag.

Praktiskt

Tillsvidareanställning på heltid
Tillträde enligt överenskommelse
Placerad i Malmö - ej hybrid
Anställningen omfattas av kollektivavtal

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