Regulatory Affairs Specialist

Regulatory Affairs Specialist

Position purpose

Act as LRA (Local RA) for all the daily activities that will ensure registrations of Radiology Medical Devices are properly done in LATAM region by submitting local dossiers, keeping country requirement table and SharePoint site folder structure updated, and ensuring the proper trackers are up to date.

Keep the information flow between global RA and local business team by ensuring the proper trackers/slides are kept accurate and up to date and by communicating HA approvals (with impact details for new/old product versions).

Facilitate the communication between RA Regional Head and Commercial Country Heads. Support assessments and labeling reviews from Global Regulatory Affairs (GRA) team for each regulated country within LATAM region.

Main activities and responsibilities

• Propose best strategy and execute dossier compilations and submissions (if applicable) according to HA (Health Authorities) and internal company requirements for LATAM countries for new registrations, renewals and variations of Radiology Medical Devices;

• Review and approve labeling materials to ensure compliance with local regulations;

• Respond to global RA assessments;

• Maintain and communicate accurate information to the local business team;

• Responsible for using and keeping CAT, SharePoint, and RIMS up to date (request support to HUB manager, GRA and/or OpEX when appropriate);

• Responsible for developing, maintaining, and improving regulatory processes as well as tracker files;

• Perform Regulatory Intelligence analysis as needed;

• Review and approve promotional materials and give regulatory guidance to the business for promotional strategies.

Position Profile

• Graduate of the Engineering, Regulatory Affairs, Life Sciences, Pharmaceutical, Chemistry or Biological Sciences;
• Bilingual: English and Spanish (Portuguese is desired);
• Strong communication skills (oral-written);
• Ability to work independently and collaboratively in a fast-paced environment;
• Excellent organizational and time management skills;
• Attention to detail and ability to manage multiple priorities simultaneously.

• Experience and knowledge in:
  • Work experience (2-4 years) in the regulatory affairs area of medical devices (preferably);
  • Strong knowledge on local regulations for main LATAM countries;
  • Proficiency in Microsoft Office Suite and regulatory software/tools (e.g., regulatory databases, document management systems) preferred.
  • Knowledge on US, EU, and Global Medical Device regulations, standards, guidance documents, international regulations (ISO, GMP, MDSAP), regulatory documentation (FSC, CFG, CoE, GMPs, ISO, legalization, apostilles, etc.).