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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 PMS and Vigilance Reporting for 3Shape’s marketed medical devices, as well as clinical evidence gathering and documentation during product development and throughout the lifespan of the product. Furthermore, being a group within 3Shape Regulatory Affairs, Scientific Affairs is responsible for ensuring global compliance within PMS, vigilance, PMCF, and clinical evaluations and for keeping up to date with changing regulatory requirements in these areas.
The job
You will be leading and developing the Scientific Affairs team, as well as acting in the roles of Scientific Manager and PMS Manager as required to accommodate changing workload and timelines. You will report to the Director of Regulatory Affairs and will interact with a wide range of stakeholders, especially R&D, Product Management, Customer Support and the product quality organization. You will also take part in cross-departmental improvement projects as well as in external audits. To do so, you set a clear direction, motivate your team to deliver, and enable the individual development of employees.
Your profile
You thrive in a role that requires adaptability and accountability whereby you will strive towards systematic processes and pragmatic solutions within your areas while ensuring that the applicable standards and regulations are upheld. You are curious and proactive by nature and take a highly structured approach to your work while being flexible and are able to reach agreements through dialogue and compromise. At the same time, you are motivated by developing people and optimizing our ways of working.
Furthermore, you have:
- Minimum 5 years´ experience from the medical device or pharmaceutical industries within clinical science, medical writing, safety, or vigilance.
- Familiarity with global legislation, guidances and standards applicable to the areas of PMS, vigilance, recall activities, and clinical evidence for the medical device industry.
- 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 regulatory 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 professional challenge in a highly dynamic globally oriented business environment.
- The chance to become part of an enthusiastic and international team with great and very skilled colleagues in an informal atmosphere.
- Healthcare insurance package
- A great location in downtown Copenhagen, Kongens Nytorv.
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.
To all agencies: Please, no phone calls or emails to any employee of 3Shape about this opening. All resumes submitted by search firms/employment agencies to any employee at 3Shape via-email, the internet or in any form and/or method will be deemed the sole property of 3Shape, unless such search firms/employment agencies were engaged by 3Shape for this position and a valid agreement with 3Shape is in place. In the event a candidate who was submitted outside of the 3Shape agency engagement process is hired, no fee or payment of any kind will be paid.
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 us
3Shape 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 1,600+ 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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 26.1.2021, men kan have været deaktiveret og genaktiveret igen.
- Afdelingsleder
- København
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