An engineering and sciences services and talent solutions firm connecting specialized experts with industry projects.
Maintain regulatory compliance and manage submission documentation for medical devices.
2 days ago ago
$36 - $40
Junior (1-3 years)
Contractor
Miami, FL
Onsite
Company Size
5,000 Employees
Service Specialisms
Technical consultation
Performance analysis
Physical development
Injury prevention and recuperation
Sports psychology
360° Marketing
Consultancy with clubs and sporting entities
Legal services
Sector Specialisms
Utilities
Power
Automotive
Food and Beverage
Consumer Products
Industrial Goods
Manufacturing
Mechanical Engineering
Role
Description
regulatory strategy
submission packages
technical documentation
device registration
adverse reporting
regulatory projects
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
bachelor's
technical writing
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
Information not given or found
Interview process
Information not given or found
Visa Sponsorship
Information not given or found
Security clearance
Information not given or found
Company
Overview
$1.3B Annual Revenue
Revenue Figure
Generated annually through a network of technical and consulting services.
27,500+ Consultants
Consultants Network
Comprises a global network of expert professionals across industries.
Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner.
Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services.
Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects.
Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems.
Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.
Culture + Values
We empower people to realize their full potential by providing opportunities to grow and learn.
We build lasting relationships based on trust, integrity, and respect.
We champion innovation, continuously seeking creative solutions.
We are committed to delivering exceptional results for our clients and employees.
We foster a collaborative environment where team members contribute to collective success.
Environment + Sustainability
2050
Target Year
The company has set a goal to achieve net-zero emissions by the year 2050.
focused on reducing its carbon footprint and enhancing environmental sustainability.
committed to making energy-efficient investments and improving operational practices for sustainability.
focuses on reducing waste and increasing recycling in its operations.
Inclusion & Diversity
This company prioritizes creating an inclusive workplace where diverse perspectives are valued.
The organization strives to increase gender diversity and empower women at all levels.
The company regularly monitors and tracks progress on gender-related diversity goals.