Regulatory Affairs

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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.

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