Regulatory Affairs Manager

We are looking for an enthusiastic, creative and hard worker member to join our regulatory/clinical affairs team.

Role Description

This is a full-time, on-site position for a Regulatory Affairs Manager in the Medical Devices industry - implants and active devices. The role involves ensuring compliance with regulatory requirements, managing regulatory submissions, maintaining a quality system, and overseeing clinical trials.

Qualifications

• Familiarity with regulatory standards and guidelines
• Experience in handling regulatory submissions (FDA/MDR) and quality systems (ISO 13485)
• Exceptional attention to detail and strong organizational skills
• Ability to work efficiently in a multitasking environment
• Excellent written and verbal communication skills
• Bachelor's degree in a relevant field