Description
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Sr. Regulatory Affairs Specialist Consultant for 12 months Contract with possibility of extension to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
The Regulatory Affairs Specialist I is responsible for providing operational and administrative support to Regulatory Affairs activities for the Medical Devices portfolio in Colombia. Under guidance from more senior Regulatory Affairs professionals, this role supports regulatory documentation management, systems updates, and project coordination to ensure compliance with applicable regulations and Clients internal requirements.
Key Responsibilities
- Support collection and tracking of regulatory documentation for INVIMA submissions.
- Perform initial completeness checks of regulatory documentation.
- Maintain organized and audit-ready regulatory files.
- Assist with execution of approved regulatory plans under supervision.
-
Update regulatory systems, databases, and trackers.
- Support coordination of regulatory projects and cross-functional requests.
- Ensure compliance with company policies and procedures.
Qualifications
Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related field. - Entry-level role; prior internships or exposure to regulated environments is a plus.
- Basic understanding of Colombian medical device regulations (Decree 4725 of 2005).
-
Proficiency in Microsoft Office tools.
Manejo de herramientas Microsoft Office.- Strong attention to detail and willingness to learn.
Alta atención al detalle y disposición para aprender.
Core Competencies & Behaviors / Competencias y Comportamientos Clave
- Learning agility and curiosity.
Agilidad de aprendizaje y curiosidad. - Attention to detail.
Atención al detalle. - Accountability for assigned tasks.
Responsabilidad sobre las tareas asignadas. - Collaboration with cross-functional teams.
Colaboración con equipos multifuncionales. - Proactive communication.
Comunicación proactiva.
Other Information / Información Adicional
This role requires responsible handling of confidential and regulated information and is performed under supervision in alignment with established regulatory procedures.
Este cargo requiere el manejo responsable de información confidencial y regulada y se desempeña bajo supervisión, de acuerdo con los procedimientos regulatorios establecidos.
- Strong attention to detail and willingness to learn.
Key Words: Regulatory Affairs, data analysis, EU MDD, EU MDR
Similar jobs
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
re you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is…
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 85,000 USD
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to…
Est. 65,000 EUR
Are you a CRA looking for the best of both worlds? Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a…
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 120,000 EUR
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 65,000 EUR
Are you a CRA looking for the best of both worlds? Would you like to work directly with a single sponsor while still enjoying the stability, global reach, and career development opportunities that come with working for a…
Est. 85,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 85,000 USD
ClinChoice is a global, full-service CRO providing clinical research services to pharmaceutical, biotechnology, medical device and consumer health companies. We are currently seeking an experienced Senior Clinical Resear…
Est. 120,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 80,000 GBP
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 125,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice…
Est. 60,000 EUR
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 120,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to…
Est. 85,000 GBP
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 60,000 EUR
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 120,000 EUR
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 80,000 EUR
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are recruiting for a Business Devel…
Est. 120,000 GBP
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 120,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice…
Est. 120,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice i…
Est. 120,000 USD
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice…
Est. 80,000 EUR
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress…
Est. 140,000 USD
ClinChoice a global CRO is recruiting for a Business Development Director to join our internal commercial team in the U.S. As a Business Development Director, you will focus on driving full clinical operations service gr…