Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location: Miami, FL (Onsite)

Industry: Medical Devices

Experience: 1-3 Years

Education: Bachelor"s Degree Required

Join a Growing Medical Device Company Making a Difference

Are you passionate about regulatory compliance, technical documentation, and bringing innovative medical devices to market? We are seeking a detail-oriented Regulatory Affairs Specialist to support regulatory submissions, product registrations, and compliance activities across U.S. and international markets.

In this role, you"ll work cross-functionally with Engineering, Quality, Operations, Marketing, and Sales teams to ensure products meet FDA and global regulatory requirements. This is an excellent opportunity for someone early in their Regulatory Affairs career who wants hands-on exposure to FDA submissions, EU Medical Device Regulation (MDR), and global regulatory processes.

What You"ll Do

• Prepare and support regulatory submissions, including FDA 510(k) and PMA applications.
• Create, maintain, and update technical documentation, technical files, and design dossiers for international markets.
• Manage product registrations, license renewals, and annual regulatory filings.
• Support adverse event reporting and vigilance reporting activities.
• Monitor and interpret evolving regulatory requirements and standards.
• Coordinate with regulatory agencies and notified bodies as needed.
• Review product labeling, manufacturing processes, and documentation to ensure regulatory compliance.
• Assist with regulatory strategies for new product development and product changes.
• Support internal audits, inspections, and regulatory compliance initiatives.
• Partner with R&D and Quality teams to facilitate timely regulatory approvals.

What We"re Looking For

Required Qualifications

• Bachelor"s degree in Engineering, Regulatory Affairs, Life Sciences, or a related field.
• 1-3 years of experience in Regulatory Affairs, Quality, or Compliance within a regulated industry.
• Strong technical writing and documentation skills.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple projects and deadlines simultaneously.
• Strong communication and cross-functional collaboration skills.

Preferred Qualifications

• Medical device industry experience.
• Experience with FDA regulations and regulatory submissions.
• Familiarity with ISO 13485, Design Controls, CAPA, and Risk Management.
• Exposure to EU Medical Device Regulation (MDR) requirements.
• RAPS membership or pursuit of RAC certification.
• Bilingual (English/Spanish) preferred.

Why Join Us?

• Opportunity to work directly with FDA and international regulatory submissions.
• Exposure to product development and global medical device compliance.
• Collaborative environment with Engineering, Quality, and R&D teams.
• Career growth within a rapidly evolving medical device organization.
• Meaningful work that helps bring innovative healthcare solutions to patients worldwide.

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 $33.65 - $38.46/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 Jul 23, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.