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Job Title: Regulatory Affairs Specialist

Job Description

We are seeking an enthusiastic, hard-working, and detail-oriented Regulatory Affairs Specialist responsible for maintaining regulatory compliance. The specialist will create regulatory policies and procedures to meet the requirements of countries where our products are distributed. This role involves developing collaborative relationships with functional partners such as Marketing, Sales, Operations, Quality, and Engineering.

Responsibilities

+ Direct and coordinate preparation of document packages for regulatory submissions from all areas of the company, including internal audits and inspections. Specifically, handle 510(k) and PMA submissions for the FDA and Technical Documentation for Europe.

+ Manage regulatory-related projects, including the implementation of new standards and regulations.

+ Oversee Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements.

+ Responsible for device registration in marketed areas.

+ Create and maintain Technical Documentation (EU) for medical devices for regulatory purposes.

+ Compile all materials required in submissions, license renewals, and annual registrations.

+ Recommend changes for labeling, manufacturing, marketing, and clinical protocol to ensure regulatory compliance.

+ Coordinate activities with regulatory agencies on defined matters.

+ Collaborate with R&D to develop strategies for the earliest possible approvals of clinical trial applications and regulatory submissions.

+ Stay informed about regulatory procedures and affairs.

Essential Skills

+ Bachelor's degree in Engineering or Regulatory Affairs.

+ 1-3 years of experience in a related field.

+ Strong technical writing skills.

Additional Skills & Qualifications

+ Knowledge of FDA regulations.

+ Experience in medical device regulatory affairs.

+ Bilingual proficiency.

+ RAPS certification is a plus.

Job Type & Location

This is a Contract to Hire position based out of Miami, FL.

Pay and Benefits

The pay range for this position is $36.05 - $40.86/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • 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 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.