Regulatory Engineer

Description

• Works with R&D to develop strategies for earliest possible approvals of clinical trials applications and regulatory submissions
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Manages the compilation of all materials required in submissions, license renewal and annual registrations.
• Responsible for Device Registration where marketed
• Coordinates activities with regulatory agencies on defined matters.
• Keeps abreast of regulatory procedures and changes.
• Responsible for the creating and maintenance of Technical Documentation (EU) for Medical devices for Regulatory purposes.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Specifically 510(k), PMA submissions for the FDA and Technical Documentation (Technical File and Design Dossiers) for Central & South America.
• Responsible for Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements
• Manages regulatory related projects including implementation of new standards and regulations.

Requirements

• 1-3 years experience
• Bachelors degree in Engineering / Technical Science
• Strong Technical writing skills

Benefits

• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Miami,FL. Application Deadline This position is anticipated to close on Jan 20, 2026.
• Health Spending Account (HSA)
• Transportation benefits
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Short and long-term disability
• Employee Assistance Program
• Medical, dental & vision

Training + Development

Interview process

Visa Sponsorship

Security clearance