Chargé affaires reglementaires

Regulatory Affairs Project Officer

Job filled

Full-time / Confirmed level

Our leading company in the manufacture and marketing of medical devices and personal protective equipment is recruiting a Regulatory Affairs Project Officer as part of its development and in order to comply with the new regulations applicable.

Job description :

The Regulatory Affairs Officer carries out all activities related to the registration and maintenance of marketing authorizations in compliance with applicable regulations

Its missions:

Reporting to the Regulatory Affairs Department and in collaboration with the Quality and Marketing Departments, you will be responsible for :

  • Define product regulations and ensure product compliance with applicable regulatory requirements;
  • Compiling and updating technical files;
  • Prepare and ensure the follow-up of test requests to testing laboratories;
  • Participate in the sending and follow-up of dossiers to notified bodies and regulatory authorities;
  • Manage requests for information from suppliers, in collaboration with the Purchasing department;
  • Establish and update regulatory documents (certificates, evaluations, declarations);
  • Develop information leaflets and check the regulatory compliance of labels, packaging and promotional documents;
  • Provide operational support to the company's various departments on regulatory issues;
  • Participate in regulatory and scientific monitoring.

Your skills:

Know-how:

  • Training A levels + 3 to A levels + 5.
    English: ability to understand and write (good level of English desired)

Savoir être :

  • Rigour ;
  • Organizational skills and autonomy;
  • Analysis and synthesis skills;
  • Writing skills ;

 

Salary: 27 to 32 KE per year depending on profile.

 

Postuler

Send resume+cover letter to:

ressourceshumaines@kolmi-hopen.com