RA Specialist
Abbott · Bogota, Colombia
RegulatoryFull-timeCompany career page
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Role summary
Abbott seeks a regulatory affairs specialist in Bogota to manage regulatory compliance and market access for medical devices across South America. The role involves coordinating submissions, monitoring regulatory changes, and collaborating with internal teams to ensure timely product registration and commercialization.
What they're looking for
- Degree in Pharmaceutical Chemistry or Biomedical Engineering
- Three years of regulatory affairs experience, preferably in medical devices
- Intermediate English proficiency, written and oral
- Knowledge of regulatory requirements for medical device registration and commercialization
- Experience managing interactions with health authorities and regulatory agencies
What you'll be doing
- Prepare, review, and submit regulatory dossiers for product registrations, renewals, and modifications to health authorities
- Track regulatory submissions through approval and maintain current product registration portfolios
- Monitor regulatory legislation changes and assess impact on device portfolio compliance
- Engage with regulatory agencies, health ministries, and industry associations on regulatory matters
- Support product launches and portfolio expansion with required regulatory documentation and technical guidance
Privacy & handoff
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