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 project manager to join us in developing innovative dental diagnostic solutions. 3Shape is a world leading technology company headquartered in Copenhagen. Our aim is to lead digital dentistry in the global market creating value for our customers and improving the lives of patients like you and me.About the departmentAs a clinical project manager you will report to the Head of Scientific Affairs and be part of our growing global Scientific Affairs organization based in Copenhagen, which currently includes 5 people. You will help documenting 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. You can expect a motivated and a fun atmosphere where one day is unlike the other.Your role in 3ShapeAs our new Clinical Project Manager, you will support our Clinical Research team in Development with regard to planning and execution of early clinical investigations as well as provide input to the clinical development plan and the clinical investigations together with the Scientific Affairs team and relevant stakeholders, such as CROs and colleagues from our Development, Regulatory Affairs, Product Management and Marketing functions. In close collaboration with the relevant stakeholders, you will develop the necessary study documents, secure ethics approval and authority approval, and manage the study from start-up to close-out. 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.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)
  • Provide support regarding clinical investigation methodology (sample sizes, endpoints, analyses/statistics)
  • Interact with clinical research organizations (CRO), competent authorities, ethics committees and external partners on join projects
  • Act as the point of contact in the interface between 3Shape and a CRO
  • Establish the required SOPs and templates in collaboration with stakeholders
  • Support the organization during internal and external audits
    • Other responsibilitiesIn addition, you will be expected to support the Scientific Affairs colleagues with:
  • Preparation and maintenance of Clinical Evaluation Plans and Reports
  • Provide input to Post Market Surveillance, 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
  • Participate and contribute to continuous improvement of processes regarding clinical evidence and PMS based on knowledge of applicable regulations, guidance’s, and best practices
  • Help answer questions from health authorities and from company affiliates/resellers regarding clinical evidence
    • Your profileWe are looking for a person with:
  • Technical or scientific degree (MSc or PhD) in a health-related field, biology, medical, biomedical engineering or similar
  • 1-3 years’ experience as Clinical Research Associate (CRA) with the ambition to take the next step and become a clinical study manager, or currently employed as a clinical study manager or clinical study manager with previous similar experience
  • Medical/scientific writing experience (including preparation of scientific articles) in the medical device settings is preferred. Statistical understanding is considered an advantage but not a requirement
  • Experience with study start-up, ethics committee (EC) and competent authority (CA) submission, site qualification, initiation, monitoring and close-out and writing and reviewing study documentation is required
  • Understanding of EU and global medical device regulations/directives, including ISO 14155:2020
  • Organized, independent with a structured pragmatic approach to drive projects
  • Ability to work in small teams with high individual exposure and responsibility
  • Excellent planning, cooperation, and communication skills is required
  • 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 can successfully handle multiple tasks while managing tight deadlines.We offerThis is an opportunity to become part of an exciting MedTech company and to make a real impact. With us you will be part of the success that 3Shape has created over the past 20 years. You will be able to work on solutions used by thousands of dental professionals worldwide and improve patient care. Creativity is in our DNA so come join our exciting journey!Your contributions and efforts are crucial to our success and by joining us you will experience.
  • An attractive office environment in downtown Copenhagen, next to Kongens Nytorv
  • Good Health Insurance package and fresh and delicious lunch and breakfast
  • Work life balance to keep you in tune with your interests including remote work for up to 2 days a week
  • An inspiring work environment in an informal atmosphere, with social, diverse, and highly skilled colleagues - we are more than 35 nationalities in our building
  • Great social work environment with many optional activities and employee clubs, ranging from wine, board games to bicycle clubs
  • Part of a fast-growing international company where diversity is considered an advantage
    • Visit our website if you want to read more about our company, mission, or why 3Shape is a great place to work!Get in touch now!Please do not hesitate to apply for this exciting opportunity at one of Denmark’s most successful and fastest-growing high-tech companies, as applications will be processed continuously. We do expect to close our search for this position as soon as possible. Please include education transcripts in your application.
    We encourage all relevant applicants to apply. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status. All qualified applicants will be given equal opportunity and the selection is based on job-related factors.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. Now, twenty years later, 3Shape is 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.


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    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 1.9.2021, 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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