Sr. Clinical Affairs Specialist
HybridCoyol, Provincia de Alajuela, Republic of Costa Rica or Coyol, Provincia de Heredia, Republic of Costa Rica
Job Summary
Lead the preparation, review, and maintenance of clinical and technical documentation, including Clinical Evaluation Reports, PMCF Plans, and study documentation. Ensure all materials comply with EU MDR, ISO 14155, GCP, and internal procedures while providing clinical input for regulatory submissions and product registrations. Support the planning and oversight of clinical investigations, monitor data quality, and serve as the subject matter expert for Regulatory Affairs, R&D, and Medical Affairs teams. Mentor junior team members, identify process improvements, and maintain current knowledge of industry trends and regulations.
Required Qualifications
- Bachelor's degree in Health Sciences, Life Sciences, Nursing, Pharmacy, Medicine, Biomedical Engineering, or a related field
- 5 years of experience in similar roles focusing on Clinical Investigation or Regulatory Affairs experience
- Strong knowledge of international medical device regulations and standards, including Good Clinical Practices (GCP), and ISO 14155
- Experience conducting systematic literature reviews and evaluating clinical data and scientific evidence
- Knowledge of risk management principles and their application within medical device development and lifecycle management
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Strong written and verbal communication skills in Spanish and English (intermediate to advanced English required)
- Availability to travel as required
Desired Qualifications
- Valid U.S. visa
- Yellow Fever vaccination
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