Regulatory Affairs Specialist

Actalent; Miami (FL); On-site; USD 47,000 - 56,000; Full time

Job summary

Actalent is seeking a Regulatory Affairs Specialist to support regulatory compliance, product registrations, and submissions for medical devices in the U.S. and internationally. Based in Kendall, FL, this role offers exposure to QA, R&D, and regulatory teams in a growing medical device organization.

The ideal candidate has strong regulatory knowledge, excellent writing skills, and comfort coordinating with agencies across markets; bilingual English/Spanish is a plus.

Qualifications

• Bachelor's degree in Engineering, Regulatory Affairs, or related technical field.
• 13 years regulatory experience preferred; strong entry-level candidates considered.
• Knowledge of FDA regulations and medical devices.
• Experience with regulatory documentation and document control.
• Strong technical writing, organization, and attention to detail.
• Bilingual English/Spanish.
• RAPS certification is a plus.
• Authorized to work in the United States; no visa sponsorship.

Responsibilities

• Prepare and coordinate documentation for regulatory submissions (FDA 510(k), PMA, EU TD).
• Maintain regulatory documentation for medical devices.
• Support FDA adverse event and international vigilance reporting.
• Manage medical device registrations in applicable markets.
• Coordinate with regulatory agencies on defined matters.
• Partner with R&D, Engineering, Quality, Operations, Sales, and Marketing.
• Assist in developing regulatory strategies for new products.
• Support internal audits and regulatory inspections.
• Stay current on applicable medical device regulations and standards.

Skills

Regulatory knowledge

Regulatory submissions

Technical writing

Cross-functional collaboration

Bilingual English/Spanish

Education

Bachelor's degree in Engineering, Regulatory Affairs, or related field

Job description

Regulatory Affairs Specialist

We are seeking a detail-oriented Regulatory Affairs Specialist to join a growing medical device company in Kendall, FL. This individual will support regulatory compliance, product registrations, regulatory submissions, and technical documentation for medical devices marketed in the U.S. and internationally.

This is a great opportunity for someone with 13 years of regulatory experience, or an early-career candidate with relevant education and a strong interest in building a career in medical device regulatory affairs.

Responsibilities

• Prepare and coordinate documentation for regulatory submissions, including FDA 510(k), PMA, and European Technical Documentation
• Create, maintain, and update regulatory documentation for medical devices
• Support FDA adverse event reporting and international vigilance reporting requirements
• Manage medical device registrations in applicable markets
• Compile documentation for regulatory submissions, license renewals, and annual registrations
• Support the implementation of new regulatory standards and requirements
• Review labeling, manufacturing, marketing, and clinical documentation for regulatory compliance
• Coordinate with regulatory agencies on defined matters
• Partner with R&D, Engineering, Quality, Operations, Sales, and Marketing to support regulatory requirements
• Assist in developing regulatory strategies for new products and product approvals
• Support internal audits and regulatory inspections
• Stay current on applicable medical device regulations, standards, and regulatory requirements

Qualifications

• Bachelors degree in Engineering, Regulatory Affairs, or a related technical/scientific field
• 13 years of regulatory affairs experience preferred; strong entry-level candidates with relevant education or experience will also be considered
• Knowledge of FDA regulations and medical devices
• Experience with regulatory documentation and document control
• Strong technical writing, organization, and attention to detail
• Ability to collaborate effectively across technical and non-technical teams
• Bilingual proficiency (English/Spanish)
• RAPS certification is a plus
• Candidates must be legally authorized to work in the United States. This position is not eligible for current or future employment visa sponsorship.

Work Environment

This is an office-based position in Kendall, FL with a growing medical device organization. The company offers a collaborative environment with exposure to Quality, Engineering, R&D, and other areas of the business.

The organization is continuing to expand its product portfolio and international presence, including markets throughout South America. This role provides an opportunity to gain broad regulatory experience while contributing to medical devices designed to support patients with serious injuries.

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 - $40.86/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Oct 30, 2026.

Workplace Type

This is a fully onsite position in Miami,FL.

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 [e-mail] 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.