Regulatory Affairs

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

København

Are you ready to pursue your career within disruptive MedTech working with 3D scanners and software medical devices in a global setting? We are looking for a Clinical Trial Manager to join us in developing innovative dental diagnostic solutions.About the TeamYou will report to the Head of Scientific Affairs and be part of our growing global Scientific Affairs organization based in Copenhagen, which currently includes 8 people. You will help generate and document the clinical evidence for the future of digital dentistry in collaboration with the entire organization and enable people across the world to enjoy better lives.Your role in 3ShapeAs our new Clinical Trial Manager, you will work with our Clinical Project Manager in Scientific Affairs in the execution of 3Shape’s clinical investigations. You will be responsible for the investigation site management and clinical investigations systems together with the Scientific Affairs team and relevant stakeholders, such as clinical research teams and clinical research organizations (CRO)s. Since this position is a new role in 3Shape, you will be able to impact the way 3Shape establishes the clinical development framework in a global context and propose ideas for alternative pathways. The role has an international and global scope, and the Clinical Trial Manager may be involved in clinical investigations ranging from early development to market approval, as well as life cycle management activities. The core focus of the job is to have a hands-on approach and assume full responsibility for the work being executed, in close collaboration with the Clinical Project Manager.Your key responsibilities
  • Plan and facilitate pre-market and post-market clinical investigations on medical devices according to ISO 14155:2020 and/or local requirements.
  • Provide support to clinical investigations documentation (clinical study protocols, informed consent form, patient information sheet, application to relevant authorities, study reports and scientific publications)
  • Establish efficient patient recruitment plans in collaboration with investigation sites and internal stakeholders (e.g. pre-screening SoMe).
  • Be responsible for the initiation of clinical investigations. This includes taking the lead on writing and/or driving the development of trial documents, manuals, and plans, as well as securing the deliverables for a timely FPFV and establishing a robust setup to run successful investigations.
  • Provide input regarding the setup of clinical trial systems and maintain a detailed overview of all planning activities.
  • Interact with investigation sites, CROs, competent authorities, ethics committees and external partners on joined projects.
  • Support the required SOPs and templates in collaboration with stakeholders.
  • Support the organization during internal and external audits.
    • Other responsibilitiesIf time allows, support the Scientific Affairs team in regard to:
  • Preparation and maintenance of Clinical Evaluation Plans and Reports.
  • Provide input to Post Market Surveillance (PMS), Post Market Clinical Follow-up (PMCF), and vigilance activities based on e.g., risk management, input from customer and complaints.
  • Provide support to Regulatory Affairs, Development, Product Management, and other 3Shape functions as required.
  • Contribute to continuous improvement of processes regarding clinical evidence and PMS based on knowledge of applicable regulations, guidance, and best practices.
  • Answer questions from health authorities and from company affiliates/resellers regarding clinical evidence.
    • Your profileWe are looking for a person with:
  • Master’s degree within a scientific field.
  • Relevant clinical operation and medical/scientific writing experience in the medical device settings. Statistical understanding is considered an advantage.
  • Experience in interacting with investigation sites and CROs.
  • Understanding of EU and global medical device regulations/directives, including ISO 14155:2020.
  • Structure to drive the processes forward.
  • Excellent planning, cooperation, and communication skills.
  • Fluent in written and oral English.
    • As a person, you are a good team player with strong interpersonal skills who thrives working with multiple stakeholders and partners in an international setting, both internally and externally. Also, you have the ability to successfully handle multiple tasks while managing tight deadlines.3Shape: An exciting, visionary, and international place to workJoin one of the most exciting Danish tech companies in the medical device industry and make an impact. With us you will be able to work on solutions used by thousands of dental professionals worldwide.We offer
  • A vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues - we are more than 40 nationalities in our DK based office.
  • An attractive healthcare package to keep you fit and well.
  • Breakfast every day, and delicious and healthy lunch cooked by our private chefs.
  • We provide a great social work environment with many optional activities and social clubs, ranging from wine & beer, board games, running to bicycle clubs.
  • Good work/life balance e.g., work from home policy for up to 2 days per week.
  • Attractive offices and R&D lab spaces in downtown Copenhagen close to Kgs. Nytorv, Nyhavn, and the Copenhagen Canals.
  • Purpose: Help improve dental patients on a global scale.
    • Get in touch now!If you are interested in this exciting opportunity, apply today. We will review the applications continuously.We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results is by welcoming diverse people into our community.
    About us3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.


    Information og data

    Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

    Arbejdsstedet er beliggende i København

    Jobbet er oprettet på vores service den 12.7.2023, men kan have været deaktiveret og genaktiveret igen.

    Rapportér
    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Apoteker
    • København
    Rapportér

    Lignende jobs

    Statistik over udbudte jobs som apotekere i København

    Herunder ser du udviklingen i udbudte apoteker i København over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal apotekere i København.

    Se flere statistikker her:
    Statistik over udbudte apotekere i København over tid

    Dato Alle jobs som apotekere
    6. november 2024 15
    5. november 2024 17
    4. november 2024 16
    3. november 2024 15
    2. november 2024 15
    1. november 2024 15
    31. oktober 2024 12
    30. oktober 2024 12
    29. oktober 2024 12
    28. oktober 2024 13
    27. oktober 2024 14
    26. oktober 2024 14
    25. oktober 2024 13
    24. oktober 2024 13
    23. oktober 2024 22
    22. oktober 2024 21
    21. oktober 2024 20
    20. oktober 2024 19
    19. oktober 2024 19
    18. oktober 2024 19
    17. oktober 2024 14
    16. oktober 2024 15
    15. oktober 2024 14
    14. oktober 2024 14
    13. oktober 2024 15
    12. oktober 2024 15
    11. oktober 2024 14
    10. oktober 2024 13
    9. oktober 2024 13
    8. oktober 2024 13
    7. oktober 2024 13
    Fold ud

    Værd at vide når du søger job som apoteker i København

    Har du også drømt om at bo og arbejde i de charmerende gader i København? Så er du ikke alene! Men drømmene bliver sjældent til virkelighed uden lidt hårdt arbejde.

    Mens København måske for nogle først og fremmest vækker billeder af hyggelige cafeer og historiske bygninger, banker et travlt erhvervsliv i hjertet af København. Hovedstaden huser et væld af brancher, men nogle skiller sig ud med et særligt højt antal ansatte.

    Bydele i København

    København byder på mere end smukke gader og hyggelige cafeer. De forskellige kvarterer har hver deres unikke atmosfære og erhvervsliv, hvilket kan påvirke din jobsøgning. Lad os dykke ned i nogle populære områder:

    Indre By: Pulsens centrum med internationale virksomheder, finansverden og detailhandel. Perfekt for jobsøgende inden for finans, jura, medier og marketing. Tempoet er højt, og konkurrencen kan være hård.

    Find ledige jobs i Indre By

    Østerbro: En blanding af moderne boliger, historiske bygninger og innovative virksomheder. Hjem til Novo Nordisk og Vestas Wind Systems. Gode muligheder inden for life science, teknologi og bæredygtige løsninger.

    Find ledige jobs i Østerbro

    Nørrebro: Multikulturelt og kreativt med studerende, kunstnere og små startups. Populært blandt unge fagfolk og jobsøgende inden for den kreative sektor og servicebranchen.

    Find ledige jobs i Nørrebro

    Vesterbro: Tidligere industriområde forvandlet til et trendy sted med restauranter, barer og designvirksomheder. Tiltrækker kreative sjæle og jobsøgende inden for mode, design og underholdning.

    Find ledige jobs i Vesterbro

    Valby: Familievenligt og roligt med gode skoler og grønne områder. Mange offentlige institutioner og virksomheder inden for service og administration. Attraktivt for børnefamilier og jobsøgende i den offentlige sektor.

    Find ledige jobs i Valby

    Amager: Et område i rivende udvikling med fokus på moderne arkitektur og bæredygtighed. Hjem til Ørestad og store virksomheder som DSV og Ørsted. Gode muligheder inden for logistik, energi og transport.

    Find ledige jobs på Amager

    Mere information om København

    Hvis du er på udkig efter et job i København, er det vigtigt, at du sætter dig grundigt ind i, hvordan jobmarkedet fungerer, og hvor i byen du vil arbejde og bo. Vi har samlet en guide med alle relevante oplysninger om København, så du kan få et samlet overblik. Læs mere om København i denne guide: København: Byen der byder på både drømmejob og spændende udfordringer

    Populære søgninger

    Lignende søgeresultater

    Se alle populære søgninger