Regulatory affairs scientists - (M/F)

Your responsibilities:
 

• Generate and update all relevant documentation (SOP, process instructions, manuals, etc.) according to the ISO 13485:2016 and the applicable regulatory requirements

• Execute and support 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 documentation or similar documents

• Review all forms of procedures, ad & promo, and all required forms of documentation applied to IVDD and IVDR

• 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 Change controls, CAPAs and raise regulatory assessments

• Plan projects and act as an interim person between different departments.

• Travel activity if required

 

 

Your profile:

• Minimum BA/BS in scientific discipline

• Experience in Regulatory Affairs at a medical device manufacturer or supplier

• Knowledge of EU (ISO 13485:2016) quality system requirements

• Knowledge of IVDR

•Knowledge of US (21 CFR 820) is considered an advantage

• Driven individual with a history of developing collaborative, cross-functional solutions

• Highly developed writing and interpersonal skills with the ability to work on diverse teams

• Working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc)

 

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 CV, covering letter and your expected salary, by post or email 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