Medical Device Regulatory Affairs Officer - Remote

Overview

Sword Health is seeking a talented and detail-oriented Medical Device Regulatory Affairs Officer to join our dynamic QARA team, focusing on compliance with international regulations and standards.

In Short

• Join a mission-driven company focused on improving patient outcomes.
• Maintain and update technical file documentation for medical devices.
• Ensure compliance with EU and US medical device regulations.
• Support digitalization initiatives within the regulatory framework.
• Oversee and coordinate project management activities.
• Contribute to the change control process.
• Work within a dynamic Quality Assurance and Regulatory Affairs team.
• Help facilitate the marketing and distribution of medical devices.
• Be part of a rapidly growing company with a strong mission.
• Collaborate with a talented team across three continents.

Requirements

• 2-3 years of experience in the medical device industry.
• Good understanding of medical device regulations.
• Experience with EU and US regulatory requirements.
• Detail-oriented with strong documentation skills.
• Ability to work collaboratively in a team environment.
• Strong project management skills.
• Commitment to quality and compliance.
• Passion for improving patient outcomes.
• Excellent communication skills.
• Ability to adapt to a fast-paced environment.

Benefits

• Opportunity to make a significant impact in healthcare.
• Work in a mission-driven environment.
• Collaborate with a diverse and talented team.
• Be part of a rapidly growing company.
• Access to professional development opportunities.
• Competitive salary and benefits package.
• Flexible working environment.
• Engagement in innovative projects.
• Supportive company culture.
• Recognition for contributions to the team.