Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?
Then come and join our global team as
Regulatory affairs scientist - (M/F)
to execute and support European and global registration of products
Your main tasks and responsibilities:
You will generate and update all relevant documentation (SOP, process instructions, manuals, etc.) according to the ISO 13485:2016 and the applicable regulatory requirements
You will prepare the necessary documents for registration of products based on regional regulatory legislations and guidance
You will establish and maintain of technical documentation or similar documents
You will review all forms of procedures, ad & promo, and all required forms of documentation applied to IVDD and IVDR
You will work closely as key team member along with R&D, Quality, Marketing and Clinical on all aspects of product life cycle
You will Review all forms of quality systems requirements such as Change controls, CAPAs and raise regulatory assessments
To find out more about the specific business, have a look at http://www.fast-trackdiagnostics.com/
Your qualifications and experience:
• Minimum BA/BS in scientific discipline
• Experience in Regulatory Affairs at a medical device manufacturer or supplier
Your attributes and skills:
• You have a good knowledge of: EU (ISO 13485:2016) quality system requirements
Knowledge of US (21 CFR 820) is considered an advantage
• You are a driven individual with a history of developing collaborative, cross-functional solutions
• You have highly developed writing and interpersonal skills with the ability to work on diverse teams
• You have working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc)
Our global team:
Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.
Check our Careers Site at http://www.fast-trackdiagnostics.com/about-us/career/
Job ID: 189146
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time