Regulatory Affairs Professional
hace 1 semana
As a Regulatory Affairs Specialist with Bayer, you will play a vital role in ensuring the successful registration of Radiology Medical Devices in LATAM. Your expertise will be essential in navigating local regulations and requirements, allowing us to bring innovative solutions to market.
Your responsibilities will include:
- Proposing and executing dossier compilations and submissions according to HA and internal company requirements for new registrations, renewals, and variations of Radiology Medical Devices;
- Reviewing and approving labeling materials to ensure compliance with local regulations;
- Responding to global RA assessments;
- Maintaining and communicating accurate information to the local business team;
- Responsible for using and keeping CAT, SharePoint, and RIMS up to date;
- Responsible for developing, maintaining, and improving regulatory processes as well as tracker files;
- Performing Regulatory Intelligence analysis as needed;
- Reviewing and approving promotional materials and giving regulatory guidance to the business for promotional strategies.
In this role, you will have the opportunity to develop and maintain your knowledge of local regulations in LATAM countries, as well as 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.).
To be successful in this position, you will need to possess strong communication skills, both written and verbal, as well as excellent organizational and time management skills. You should also be able to work independently and collaboratively in a fast-paced environment, prioritizing multiple tasks simultaneously.
We are looking for candidates with a background in Engineering, Regulatory Affairs, Life Sciences, Pharmaceutical, Chemistry, or Biological Sciences, who hold a Graduate degree. Proficiency in Microsoft Office Suite and regulatory software/tools is preferred. Bilingualism in English and Spanish is required, with Portuguese being a desirable additional language skill.
We estimate the salary for this position to be around $80,000 - $110,000 per year, depending on experience and qualifications.
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