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 work closely as key team member along with R&D, Quality, Marketing and Clinical on all aspects of the product life cycle.
Your tasks and responsibilities:
You will Generate and update all relevant documentation (SOP, process instructions, manuals, etc.) according to the ISO 13485 and the applicable regulatory requirement
You will execute European and global registration of product
You will prepare the necessary documents for registration of products based on regional regulatory legislation and guidance
You will review all forms of procedures, ad & promo, and all required forms of documentation applied to IVDD
You will review all forms of quality systems requirements such as CAPAs and raise regulatory assessments keeping up to date with changes in regulatory legislation and guidelin
To find out more about the specific business, have a look at http://www.fast-trackdiagnostics.com/
Your qualifications and experience:
Master's degree or Ph.D. in Biology or related field, or equivalent combination of education and experience
Minimum of five years Regulatory Affairs experience, with at least three years of direct experience in a leadership role
Knowledge of EU (ISO 13485) quality system requirements
Knowledge of new IVDR and US (21 CFR 820) is considered an advantage
Your attributes and skill
You have an excellent planning and organizational skills, and close attention to detail are essential
You have direct experience managing high-performing teams and developing team members
You are capable of managing multiple projects simultaneously
You have superior oral and written communications skills
You are a proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis
You are Fluent in written and spoken English. Any other European language is an advantage
You have willingness to travel.
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: 119598
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time