Regulatory Affairs Project Officer
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
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.
- 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.