international regulatory affairs specialist.

Educational Background:

Bachelor’s Degree: In a relevant field such as Life Sciences, Engineering, Biomedical Sciences, or a related discipline.

Advanced Degree (Preferred): Master’s degree or higher in Regulatory Affairs, Clinical Research, or a related field.

Professional Experience:

Regulatory Experience: Minimum of 3-5 years of experience in regulatory affairs, specifically within the medical device industry.

Knowledge of Regulations: Proven experience with FDA regulations, EU MDR, ISO standards (e.g., ISO 13485, ISO 10993, ISO 14971), and other relevant global regulations.

Communication Skills: Excellent written and verbal communication skills for interacting with regulatory agencies, preparing reports, and drafting regulatory documents.

Project Management: Strong organizational and project management skills to handle multiple regulatory submissions and projects simultaneously.

Problem-Solving: Strong analytical and problem-solving skills to address regulatory challenges and provide solutions.

Attention to Detail: High level of accuracy and attention to detail in reviewing and preparing regulatory documents.

Language Skills: Proficiency in English language

Regulatory Knowledge: In-depth understanding of medical device regulations, guidance documents, and regulatory processes.

Documentation Expertise: Proficient in preparing and reviewing regulatory submissions (e.g., 510(k), PMA, CE Marking applications).

Compliance Management: Experience in ensuring compliance with regulatory requirements and managing regulatory audits and inspections.

Data Analysis: Ability to analyze technical data and understand scientific principles related to medical devices.