Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist page is loaded
Senior Regulatory Affairs SpecialistApply locations Bogota D.C., Colombia time type Full time posted on Posted 3 Days Ago job requisition id R540442 Work Flexibility: Hybrid What you will do
Execute regulatory affairs (RA) activities in accordance with defined procedures and processes. Collect, organize, and maintain files on local, regional, and global RAQA intelligence. Identify the need for new regulatory procedures and SOPs, participating in their development and implementation.
Suggest and support continuous improvement initiatives across RA processes. Achieve established targets, KPIs, and objectives for RA activities. Provide support to LATAM/country RA teams and assist local RAQA leaders with data collection for performance, risks, and issues reporting.
Act as a subject matter expert for the local business, supporting the development and deployment of systems and procedures. Facilitate the integration of new acquisitions, ensuring RAQA system integration, and support talent recruitment, onboarding, and development at the local office. What you will need
Hold a BSc degree in a relevant field; an advanced degree is preferred, and RAC certification is also advantageous.4+ years of experience in regulatory affairs. Conversational level in English. In-depth knowledge of regulatory requirements for medical devices, including the Medical Device Directive, EU Medical Device Regulations, Quality Systems, and Post Market Surveillance.
Experience in facilitating meetings with regulatory agencies, conducting internal and external audits, and preparing necessary briefings and documentation. Travel Percentage: 0%
#J-18808-LjbffrInformation :
- Company : Stryker Corporation
- Position : Senior Regulatory Affairs Specialist
- Location : Bogotá, Bogotá D.C.
- Country : CO
Attention - In the recruitment process, legitimate companies never withdraw fees from candidates. If there are companies that attract interview fees, tests, ticket reservations, etc. it is better to avoid it because there are indications of fraud. If you see something suspicious please contact us: support@jobkos.com
Post Date : 2025-05-26 | Expired Date : 2025-06-25