Regulatory Affairs

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3Shape offers a unique opportunity to work as a Scientific Manager in the center of Copenhagen. At 3Shape, we have been part of disrupting the dentistry market with our technology since the beginning of 2000, and we have only just begun. We create value for our customers and improve the lives of patients like you and me on a global scale by improving treatment and diagnostics for dental patients through our innovative software and 3D scanners for the dental professionals everywhere. Therefore, this opportunity will help you develop within future-disruptive health technologies by being part of shaping and maintaining the scientific foundation of our products globally. About the position The main purpose of the position is to develop and maintain our clinical evidence documentation as well as to facilitate post-market activities hereby supporting our products regarding safety and clinical performance as well as product claims. Moreover, the job responsibilities more specifically include:
  • Preparation and maintenance of Clinical Evaluation Plans (CEPs) and Reports (CERs)
  • Ensure that the clinical evidence requirements and the CEPs and CERs for our products comply with current and future global medical device guidance and regulations
  • Coordinate the set-up of proactive product evaluation protocols
  • Provide support to product development teams regarding clinical aspects
  • Provide support to product marketing campaigns with regards to clinical claims based on clinical evidence
  • Contribute to continuous improvement of processes regarding clinical evidence
  • Answer questions from health authorities and from company affiliates/resellers regarding clinical safety and performance
    • The Scientific Affairs team
  • The team consists of 3 Scientific Managers and a Post-Market Surveillance (PMS) Manager with academic backgrounds and experience within medical devices and pharmaceuticals. Together we handle clinical evidence gathering and documentation during product development and throughout the lifespan of the product as well as PMS and Vigilance Reporting for 3Shape’s marketed medical devices.
  • Furthermore, being a group within 3Shape Regulatory Affairs, Scientific Affairs is responsible for ensuring global compliance within clinical evaluations, Post-Market Clinical Follow-up, PMS as well as vigilance and for keeping up to date with changing regulatory requirements in these areas.
    • Your profileWe are looking for a colleague with:
  • A Master’s degree within a scientific field and preferably a Ph.D.
  • Minimum 2 years of relevant clinical/dental/medical writing experience
  • Experience working in a regulated environment, preferably with medical devices or pharmaceuticals
  • Experience within academia, preparation of scientific articles (including statistical understanding) is an advantage
  • Knowledge of medical device regulations (EU MDR, FDA, ISO 13485, MEDDev guidances)
  • Excellent planning, cooperation, and communication skills
  • Fluent in written and oral English
    • As a person, you are a skilled team player with strong interpersonal skills who enjoys working with different stakeholders and partners, both internally and externally. Also, you can successfully lead multiple projects and simultaneously manage tight deadlines.Life at 3ShapeIn 3Shape we are proud of our empowered, team-centric working culture where you can be sure to meet highly skilled, educated, and diverse teammates (in our HQ alone we are 40 different nationalities). Working for 3Shape means that you will experience:
  • A vibrant, young, and informal working environment with diverse, and highly skilled, and supportive colleagues with “fun” as a core value
  • An opportunity to change dentistry together with dental professionals across the world by ensuring innovative solutions that provide superior patient care
  • Sparring, coaching, feedback, and a personal development plan to pace your career development and to sharpen your toolbox
  • Breakfast every day, and delicious healthy lunch
  • A great social work environment with many optional activities and employee clubs, ranging from wine tasting, board games to bicycle and scuba diving
  • Flexible working e.g., possibility work for remotely up to 2 days a week
  • Healthcare insurance package
  • A great location in downtown Copenhagen, next to Kongens Nytorv
  • Let´s change dentistry together!
    • How to applyIf you wish to apply for this exciting opportunity at one of Denmark’s most successful and innovative high-tech companies, click on the ‘Apply Now’ button to submit your CV. We welcome global applicants that are willing to relocate. Please apply as soon as possible as we will interview on a rolling basis. If you have any questions, please contact Scientific Manager Miriana Quattromani at +45 3177 3058.

    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 1,700+ 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 Facebook.


    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 15.2.2022, 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
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