Regulatory Affairs Coordinator

Job Description

We are seeking a diligent and detail-oriented Regulatory Affairs Associate to join our team. The ideal candidate will be responsible for the preparation of 510(k) submissions, gathering necessary documentation, collaborating with team members to gather intelligence, and assembling the full submission package for approval by the Vice President. This role requires a strong understanding of regulatory requirements and excellent organizational skills.

Responsibilities

• Prepare 510(k) submissions, ensuring accuracy and compliance with regulatory requirements.
• Gather and compile necessary documentation for regulatory submissions.
• Collaborate with cross-functional team members to gather relevant information and data.
• Prepare and assemble the full submission package for final review and approval by the Vice President.
• Maintain up-to-date knowledge of regulatory requirements and industry standards.
• Assist in responding to regulatory inquiries and requests for additional information.
• Ensure all regulatory activities are completed in a timely and efficient manner.

• Previous experience in regulatory affairs, preferably in the medical device industry.
• Strong understanding of 510(k) submission process for coordination
• Excellent organizational skills and attention to detail.
• Ability to work collaboratively with cross-functional team members.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• Bachelors degree in regulatory affairs or a related field, or experience
• Certification in Regulatory Affairs (RAC) is nice to have.
• Experience with other types of regulatory submissions (e.g., PMA, IDE).

This position requires working onsite five days a week, with some flexibility on times once the person is up and running. The role involves collaboration with others.

The pay range for this position is $45.00 - $50.00/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 Mar 27, 2025.

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.

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 ... for other accommodation options.