Regulatory Affaires Scientist - Luxembourg

Your missions :

• 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

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