Regulatory Affairs

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Are you ready to pursue or continue your career within disruptive MedTech working with 3D scanners and software medical devices in a global setting? Then 3Shape offers a unique opportunity to work as Post-Market Surveillance Manager in our Scientific Affairs team in the center of Copenhagen at Kongens Nytorv. 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.The Scientific Affairs TeamThe Post-Market Surveillance (PMS) Manager position is part of 3Shape´s Scientific Affairs team consisting of 2 PMS Managers and 4 Scientific Managers 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.The positionAs our new PMS Manager, you will lead and facilitate PMS activities in accordance with relevant global regulations to support our products regarding safety and performance. Interaction with a wide range of stakeholders - and here especially with Development, Customer Support, Product Management, Global Sales, Resellers, and external consultants worldwide – does in addition characterize this role. Moreover, the job responsibilities specifically include:
  • Ensure that the PMS requirements for our products comply with current and future global medical device regulations, including the EU Medical Device Regulation (MDR)
  • Contribute to continuous improvement of PMS processes and procedures and conduct training as appropriate
  • Collect and interpret relevant PMS data from multiple stakeholders, including writing PMS plans, PMS reports, and Periodic Safety Update Reports
  • Provide a clinical safety and usability perspective to the overall Risk Management Process and individual Product Risk Assessments
  • Interact with authorities to fulfill the regulatory requirements related to PMS, Vigilance, and Trend Reporting (e.g. reporting of serious incidents and Field Safety Corrective Actions)
  • Support the organization during internal and external Audits
    • Your profileWe are looking for a colleague with:
  • A Master’s degree within a scientific field
  • Relevant Quality, Regulatory and/or Vigilance operational experience from a regulated industry, preferably the medical device industry
  • Knowledge of medical device regulations (EU MDR, FDA, ISO-13485, ISO-14971, MEDDEV guidances)
  • A structured working approach to drive processes forward
  • Excellent planning, project management, cooperation, and communication skills
  • Fluent in written and oral English
    • As a person, you are a great team player with strong interpersonal skills who thrives working with multiple stakeholders and partners, both internally and externally. Also, you can successfully handle multiple tasks while managing 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 to work remotely for 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 Senior Director Antje Marquardsen at +45 2494 1449
    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 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 24.3.2022, 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.
    • Apoteker
    • København
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