Regulatory Affairs Specialist
hace 4 semanas
**Regulatory Affairs Specialist**
**Position Overview**
Bayer is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico. As a key member of our Regulatory Affairs department, you will be responsible for ensuring the compliance of our medical devices with local regulations in the LATAM region.
**Key Responsibilities**
- Act as LRA (Local RA) for all daily activities related to the registration of Radiology Medical Devices in LATAM countries.
- Submit local dossiers, maintain country requirement tables, and update SharePoint site folder structures.
- Ensure proper trackers are up to date and facilitate communication between global RA and local business teams.
- Support assessments and labeling reviews from Global Regulatory Affairs (GRA) team for each regulated country in LATAM.
**Requirements**
- Graduate degree in Engineering, Regulatory Affairs, Life Sciences, Pharmaceutical, Chemistry, or Biological Sciences.
- Bilingual: English and Spanish (Portuguese is desired).
- Strong communication skills and ability to work independently and collaboratively in a fast-paced environment.
- Excellent organizational and time management skills, with attention to detail and ability to manage multiple priorities simultaneously.
**Preferred Qualifications**
- Work experience (2-4 years) in the regulatory affairs area of medical devices.
- Strong knowledge of local regulations for main LATAM countries.
- Proficiency in Microsoft Office Suite and regulatory software/tools.
**About Bayer**
Bayer is a global enterprise with a long history of innovation and commitment to excellence. We offer a dynamic and supportive work environment, with opportunities for professional growth and development.
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