- Details
- Highlights
- Company
- You are responsible for the regulatory support of our product line "Sterile single-use endoscopes" throughout the entire product lifecycle.
- You support and take over the coordination in the creation of technical documentation for assigned medical product groups.
- You identify global regulatory requirements for assigned medical product groups.
- You take over the development of testing and approval strategies for global distribution.
- Analysis and optimization of processes and procedures are also part of your tasks.
- You monitor compliance with regulatory requirements throughout the product lifecycle.
- You work closely with development teams and business partners from other departments.
- You ensure targeted training of development teams regarding regulatory requirements.
- Completed scientific/technical studies
- Several years of experience in the field of Regulatory/Quality Product Lifecycle for sterile medical products, preferably for sterile single-use endoscopes
- Knowledge of common sterilization procedures and regulatory requirements for the production of sterile medical products, preferably for sterile single-use endoscopes
- Familiarity with relevant international and regional standards, guidelines, and regulations for sterile medical products, preferably for sterile single-use endoscopes
- Expertise in medical-technical products (preferably endoscopy/imaging and sterile products) is desirable
- Confident presence in global project structures
- Communicative and analytical skills
- Independent and structured working style
- Very good English skills, Estonian language would be beneficial
- Interesting and challenging work
- Opportunity to contribute to the production of novel medical instrumentation
- Opportunity to work in an international and well-known company
- A supportive team and modern working-environment
- Sport opportunities (volleyball, yoga, walking and running series)
- Recognising birthdays and other personal important occasions
- Various team and joint events
Candidates are expected to submit a CV in English.
Location
- Estonia
Paernu mnt 556b
Time of work
- Full-time
Marit Hõbemägi
Karl Storz on Euroopa suurim kõrgtehnoloogilise kirurgiainstrumentaariumi tootja, peakorteriga Saksamaal, loodud 1945.aastal. Karl Storz'i firmamärk on esindatud kõikides maailmajagudes ning see on kujunenud omal alal kvaliteedi ja usaldusväärsuse sümboliks.
Karl Storz Video Endoscopy Estonia OÜ on Storz'i grupi kiiremini arenevaid arendus- ja tootmisüksusi.
1994. aastal Eestis alguse saanud ettevõtte kogemus endoskoopide tootmises ja pühendunud töötajad on põhjuseks, miks maailmanimega kontsern rakendab tehnoloogia uusimaid saavutusi seeriatootmises just Eesti tütarettevõttes.
Ettevõttes on meditsiiniliste ja veterinaarias kasutatavate paindendoskoopide arendustiim, tootmisüksused, kus erinevate tehnoloogiate abil valmivad instrumendid alates eelkoostamisest kuni lõppkoostamiseni ja remondiosakond koos kõigi vajalike tugiüksustega. Kokku on meil täna 300 töötajat.