Regulatory Affairs Job at Bayer, Mexico
Are you a Regulatory Affairs professional looking to work with medical devices in a global pharmaceutical company? This Regulatory Affairs Job opportunity at Bayer Careers in Mexico offers a dynamic Specialist role where you can manage regulatory submissions, ensure compliance, and contribute to product approvals across LATAM countries.
About the Company:
Bayer is a global leader in pharmaceuticals, consumer health, and crop science. Known for innovation and a strong commitment to improving lives, Bayer focuses on delivering high-quality healthcare solutions while fostering a diverse and inclusive workplace culture.
Job Details:
- Job Title: Regulatory Affairs Specialist
- Reference Code: 863585
- Location: Ciudad de México
- Job Type: Full-Time
- Employment Type: Regular
- Functional Area: Regulatory Affairs
- Division: Pharmaceuticals
Key Responsibilities:
- Act as Local Regulatory Affairs (LRA) for Radiology Medical Devices in LATAM
- Manage dossier submissions, registrations, renewals, and variations
- Maintain regulatory trackers, databases, and SharePoint documentation
- Ensure communication between global RA teams and local business teams in this Regulatory Affairs Job in Mexico
- Support labeling reviews and ensure compliance with local regulations as a Regulatory Affairs Specialist at Bayer Careers
- Develop and implement regulatory strategies for LATAM markets
- Perform regulatory intelligence and analysis
- Review and approve promotional materials for compliance with this Regulatory Affairs Job
- Coordinate with Health Authorities and internal stakeholders
Educational Requirements for this Job:
- Degree in Engineering, Regulatory Affairs, Life Sciences, or Biological Sciences
Skills Required:
- Bilingual proficiency in English and Spanish (Portuguese is a plus)
- Strong communication and interpersonal skills
- Knowledge of LATAM medical device regulations
- Understanding of global regulations (US, EU, ISO, GMP, MDSAP)
- Experience with regulatory documentation and submissions
- Proficiency in Microsoft Office and regulatory tools
- Strong organizational and time management skills
- Ability to work independently and manage multiple priorities
Benefits of the Regulatory Affairs Job:
- Opportunity to work with a global pharmaceutical leader
- Exposure to international regulatory frameworks and compliance
- Career growth in regulatory affairs and medical devices
- Dynamic and collaborative work environment
- Inclusive and diverse workplace culture
- Opportunity to impact healthcare across the LATAM regions
