Regulatry Affairs Specialist

Job Description

Regulatory Affairs Specialist

Are you a seasoned Regulatory Affairs Specialist looking to take the next step in your career within an organization that values innovation and quality?

Are you ready to contribute to a rapidly growing spinal implant company and make a real impact by helping bring life-changing products to market?

If so, we invite you to join our Regulatory Affairs team and support compliance with local and global regulatory standards!

Key Responsibilities :

As a Regulatory Affairs Specialist, you'll be crucial in ensuring our products comply with all applicable regulatory standards. Working alongside cross-functional teams, you'll navigate regulatory requirements and contribute to the smooth market entry of our medical devices globally.

• Prepare and maintain documentation for product registrations
• Keep regulatory databases current
• Oversee registration lifecycles in our Registration Information Management System
• Assist in creating and updating MDR Technical Documentation
• Support 510(k) submissions as needed
• Collaborate with teams in R&D, marketing, and manufacturing to assess regulatory implications of project changes
• Communicate with international agents, distributors, and authorities to oversee global product registrations
• Assist in preparing PMS / PSUR reports for product evaluations
• Participate in internal and external audits conducted by regulatory authorities
• Support regulatory assessments for new standards and regulations
• Collect, analyze, and interpret Regulatory Metrics and Key Performance Indicators

Qualifications :

LI-OG1