- opportunity in regulatory affairs in health industry
- responsible to consolidate the relation between the company and the government i
Sobre nuestro cliente
leading global company of medical devices and solutions
Reporting to the LATAM Regualtory tem and the Argentinian GM, their main responsibilities will be; To undertake the medical device registration works in International area.
To maintain active communication with consultants and relating authorities（ANMAT or other accredited body）; solving registration problems, pushing forward the registration process and guarantee a favorable registration result。
To maintain active communication with consultants, and relating authorities（ANMAT or other accredited body）; solving registration problems, pushing forward the registration process and guarantee a favorable registration result。
Interlocutor to public health authorities and will act as a Sanitary Responsible before government institutions.
Ensure approval procedures submitted to the ANMAT regarding Marketing Authorizations to promote and sell medical devices.
Prepare application forms and monitor all processes before the ANMAT.
Follow up with Corporate for all technical and legal information for the preparation and assembly of dossiers for marketing authorization as per ANMAT standards, current local regulations and company policies.
To work very close to Third Parties to guarantee the acceptance of all documents to be submitted to ANMAT.
Coordination and monitoring of activities related to the Integrated Services Center ANMAT and Analytical Control Commission.
To review all advertising and promotional materials to be submitted before ANMAT.
To prepare, in case, the labeling project.
Managing and updating databases and monitoring the time-tables/calendar.
Preparation of import permits, modifications and renewals.
Ensure the receipt, recording, classification and reporting of adverse reactions on time and prepare reports (Technoviglance), to guarantee the safety of our medical devices.
Implementation of regulatory actions taken for safety reasons.
Meet with deadlines of any other safety information required by the competent authorities
Establish training programs in terms of Techno vigilance for our customers.
Page Group Argentina is acting as an Employment Agency in relation to this vacancy.
Perfil buscado (Hombre / Mujer)
We are looking for Bachelor degree in Chemistry, Engineering, Automation Engineering, Bio medical Engineer or similar
Medical Discipline with a Minimum 3 years experience in medical devices or pharmaceutical company as Coordinator or Officer for the Regulatory Affairs Department.