What are the responsibilities and job description for the Regulatory Affairs Specialist position at Actalent?
Description
DESCRIPTION:
The Regulatory Specialist shall be an enthusiastic, hard-working, detail-oriented individual primarily responsible for maintaining Regulatory Compliance. The Regulatory Specialist shall create regulatory policy and procedures to meet the requirements of the countries where client distributes its products.
This position will proactively develop collaborative relationships with all functional partners including Marketing, Sales, Operations, Quality and Engineering.
RESPONSIBILITIES:
• 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 Europe.
• Manages regulatory related projects including implementation of new standards and regulations.
• Responsible for Adverse Event (US) and Vigilance Reporting (OUS) regulatory requirements
• Responsible for Device Registration where marketed
• Responsible for the creating and maintenance of Technical Documentation (EU) for Medical devices for Regulatory purposes.
• Manages the compilation of all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Coordinates activities with regulatory agencies on defined matters.
• Works with R&D to develop strategies for earliest possible approvals of clinical trials applications and regulatory submissions
• Keeps abreast of regulatory procedures and changes.
Skills
Regulatory affairs, Regulatory, document control, bilingual, fda, medical device, RAPS
Additional Skills & Qualifications
-Bachelors degree in Engineering / Regulatory Affairs
-1-3 years experience
-Strong Technical writing skills
Job Type & Location
This is a Contract to Hire position based out of Miami, FL.
Pay and BenefitsThe 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 TypeThis is a fully onsite position in Miami,FL.
Application DeadlineThis position is anticipated to close on Jan 13, 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 actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $36 - $41