Regulatory Affairs Specialist

Education & Special Trainings :

• Degree :   At least a bachelors degree, preferably in healthcare, medical, engineering, or related fields.
• Knowledge :   Basic understanding of ISO 13485 and US FDA regulations related to medical devices.

Qualifications & Experience :

• Experience :   Minimum of 2 years of relevant regulatory and quality assurance experience in an international company.

Physical & Mental Requirements :

• Detail-Oriented :   Strong attention to detail.
• Communication :   Excellent communication skills.
• Influence :   Ability to motivate others to take action.
• Ownership :   Hands-on approach with the ability to implement swiftly and effectively by taking ownership and accepting responsibility.
• Ethics :   High ethical standards and integrity.
• Organization :   Well-organized with logical thinking.
• Planning :   Good at planning processes, patient, and a strong sense of responsibility.

Skills Required

Regulatory Compliance, Clinical Trials, Risk Management