We are now looking for a
Senior Regulatory Affairs Manager
to support our global product registrations and compliance with the regulatory requirements. The role is responsible for CE marking (EU MDR) and Notified Body change notifications for our dental 2D and 3D imaging products. Senior RA Manager works together with the regional Regulatory Affairs teams and R&D developing most effective registration paths for new software and hardware products, and their accessories.
As a Senior Regulatory Affairs Manager you will be responsible for developing and maintaining regulatory processes and tools, and attending regulatory audits as necessary.
You will report to Senior Regulatory Affairs Manager of KaVo Imaging Business Unit.
We expect you to
hold an Engineering, Business or equivalent degree
have experiences with EU MDR, US FDA, Health Canada, China NMPA registrations and regulatory requirements
have demonstrated knowledge of EU and US UDI regulations
have knowledge of applicable IEC and ISO standards and a passion to learn also national and international x-ray standards
have fluent communication skills both in Finnish and English
Additionally, the following will be considered an advantage:
knowledge of MDSAP program
experiences with implementing requirements for Material Safety and Restrictions (Biocompatibility, RoHS, SCIP, Cal Prop 65)
drive for the application of Lean methodology and processes
As a person, you are self-motivated and able to work independently, yet an efficient team player, who strives for reaching the goals. You take initiative, learn quickly and enjoy facing challenges and solving problems. You have a sense of urgency and great attention to detail. You also enjoy working in an international company and multicultural environment.
We offer you inspiring challenges in a growing global healthtech business and an opportunity to work within a strong Lean culture. The position offers interesting and varying responsibilities, cross-functional teamwork and an attractive opportunity to excel your professional skills.
The position is based in Tuusula, Finland where the R&D center for KaVo dental 3D imaging resides. The role allows working remotely, especially when working with the regional RA teams.
For more information please contact Rainer Harjunpää, Sr. RAQA Director of KaVo Imaging at firstname.lastname@example.org
Please submit your application with a salary expectation and your CV by April 30, 2021 via our online recruitment system by clicking APPLY.