Senior Regulatory affairs scientist - (M/F)

Your responsibilities:

  • Generate and update all relevant documentation (SOP, process instructions, manuals, etc.) according to the ISO 13485 and the applicable regulatory requirements
  • Execute European and global registration of products
  • Prepare the necessary documents for registration of products based on regional regulatory legislations and guidance
  • Establish and maintain of technical files
  • Review all forms of procedures, ad & promo, and all required forms of documentation applied to IVDD
  • Work closely as key team member along with R&D, Quality, Marketing and Clinical on all aspects of product life cycle
  • Review all forms of quality systems requirements such as CAPAs and raise regulatory assessments
  • Plan projects and act as an interim person between different departments
  • Travel activity if required
  • Act as a team Lead for Regulatory Team
  • Lead the transition to new EU IVDR
  • Ensure effective global product registration

 

 

Your profile:

  • Master's degree or PhD in Biology or related field, or equivalent combination of education and experience
  • Minimum of five years Regulatory Affairs experience, with  at least three years 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
  • Excellent planning and organizational skills, and close attention to detail are essential
  • Direct experience managing high-performing teams and developing team members
  • Capable of managing multiple projects simultaneously
  • Superior oral and written communications skills
  • Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis
  • High flexibility
  • Fluency in written and spoken English is essential. Any other European language is an advantage
  • Willingness to travel

 

The position will be based in Luxembourg.

 

If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including resume, covering letter and your expected salary, by post or e-mail to the following address:

 

Fast Track Diagnostics Luxembourg SARL

Ms. Elisabeth CHACTOURA

29, rue Henri Koch- L-4354/ Esch s/ Alzette

e-mail: Elisabeth.Chactoura@fast-trackdiagnostics.com