Senior Regulatory Specialist - Remote

Overview

The purpose of the Senior Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.

In Short

• Prepare and maintain pre-market submissions or post-market change submissions for various markets.
• Provide project-level regulatory strategy and support for new product development projects.
• Act as project team RA lead member.
• Assess and approve post-market changes.
• Assess and approve product and process Nonconformances and deviations.
• Own and execute CAPA for Regulatory processes.
• Minimum 5 years experience in FDA/ISO medical devices quality management system standards required.
• 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required.
• Bachelor’s Degree from an accredited institution required.
• Technical writing skills required.

Requirements

• Bachelor’s Degree from an accredited institution required.
• Minimum 5 years experience in FDA/ISO medical devices quality management system standards required.
• 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required.
• Technical writing skills required.

Benefits

• Full-time employment.
• Remote work flexibility.
• Opportunity to work on regulatory compliance for medical devices.
• Engagement in project management for new product development.
• Collaborative work environment.