Regulatory Affairs Specialist

Descrizione del lavoro:

Regulatory Affairs Specialist

Ever feel burnt out by bureaucracy? Us too. That's why we're changing the way we work- for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here: https://www.bayer.com/en/strategy/strategy

YOUR TASKS AND RESPONSIBILITIES

* 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.

* 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 internal tools/data up to date.

* 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.

WHO YOU ARE

* 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.

* 2 to 4 years of experience 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.

At Bayer we believe in diversity, equity and inclusion. We aim to create an environment in which everybody can feel authentic, respected and equally valued. Every day we strive to reflect our values through our people's unique capabilities, self-experiences, and aspirations. We intentionally seek diversity, to enable our people to bring their fullest potential out and encourage others to likewise do so. Our company wins when we leverage our capabilities to lead the cultural transformation in our business, positively impacting society.

Candidates who meet the requirements based on the job profile will be considered for employment regardless of physical disability, race, color, religion, sex, age, sexual orientation, gender identity and will not be at a disadvantage if unemployed.

Application Period:

03/16/2026 - 03/27/2026

Reference Code:

863585

Division:

Pharmaceuticals

Location:

Mexico : Ciudad de México : Ciudad de México

Functional Area:

Regulatory Affairs

Position Grade:

H

Employment Type:

Regular

Work Time:

Full Time

Location

CDMX