Regulatory Affairs

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3Shape is a Danish MedTech company and specializes in developing 3D scanning and software technology solutions that enables dental and hearing professionals to treat more people, more effectively and with improved care. And right now, we are embarking an exciting journey changing the approach for dental treatment and diagnosis. If you are looking for a challenging job with diverse tasks and clever colleagues related to investigating and documenting clinical safety and effectiveness of 3Shape’s products being developed and marketed, then this could be the right job for you.The Scientific Affairs TeamYou will meet an engaged team of 3 Scientific Managers and 2 Post-Market Surveillance (PMS) Managers with diverse 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. In 3Shape we believe in 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). Additional colleagues will join the team in 2022.The position

Motivation and development of the Scientific Affairs team members is a key focus for this role, as well as participation in the development of clinical strategies for new indications, take part in cross-departmental improvement projects as well as in external audits. Reporting to the Senior Director of Regulatory Affairs, you will interact with a wide range of stakeholders, especially R&D, Product Management, Customer Support and our subsidiaries.Your profileYou are curious and proactive by nature and take a highly structured approach to your work while being flexible and can reach agreements through dialogue and compromise. At the same time, you are motivated by developing people, proposing alternative solutions, and optimizing our ways of working.Furthermore, you have:
  • Minimum 5 years´ experience from the medical device or pharmaceutical industries within clinical science, clinical investigations, medical writing, and/or PMS
  • Leadership experience (people management or project management). Alternatively, you have an interest in leading and developing people.
  • Have experience with collaboration and communication with management teams on planning and executing clinical strategies.
  • An interest for working in a multi-cultural environment with people who have various educational or work backgrounds.
  • Excellent communication skills; fluent written and spoken English.
    • We offer
  • An opportunity to change dentistry together with dental professionals across the world by ensuring innovative solutions that provide superior patient care are made available globally
  • A company culture built on mutual respect, openness, strong team spirit and high performance
  • The chance to become part of an enthusiastic and international team with great and very skilled colleagues in an informal atmosphere
  • Breakfast every day, and delicious and healthy lunch
  • A great social work environment with many optional activities and employee clubs, ranging from wine, yoga and board games to bicycle clubs
  • Work/life balance to keep you in tune with your interests e.g., possibility for remote work for up to 2 days a week.
  • Healthcare insurance package
  • A great location in downtown Copenhagen
    • Get in touch now!If you think you’re up for the challenge, we’d be happy to receive your application including motivational cover letter and CV. Please apply as soon as possible as we will interview continuously. 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 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 2.3.2022, 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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