Job Title: Regulatory SpecialistJob Description:

　　Join our dynamic team as a Regulatory Specialist, where you will play a crucial role in maintaining Regulatory Compliance. Your primary responsibility will be to create and manage regulatory policy and procedures for various countries, ensuring our products meet all necessary requirements. This role requires a proactive approach to develop collaborative relationships across multiple departments such as Marketing, Sales, Operations, Quality, and Engineering.

　　You will be directly involved in coordinating and preparing document packages for regulatory submissions, managing regulatory projects, and ensuring compliance with Adverse Event and Vigilance Reporting regulations. Moreover, you will be tasked with Device Registration in marketed territories and the creation and maintenance of Technical Documentation for Medical devices in the EU.

　　This role is pivotal in guiding changes for labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance. You will also coordinate with regulatory agencies on specific matters and work with R&D to develop strategies for timely approvals of clinical trials applications and regulatory submissions. Staying updated with regulatory procedures and changes is essential for success in this position.

　　Hard Skills:

　　Regulatory Affairs expertise

　　Document Control proficiency

　　Comprehensive FDA Knowledge

　　Bilingual abilities

　　Strong Technical writing skills

　　Soft Skills:

　　Detail-oriented and highly organized

　　Excellent communication and interpersonal skills

　　Ability to work collaboratively across various departments

　　Proactive and enthusiastic approach to work

　　Additional Skills & Qualifications:

　　Bachelor's degree in Engineering / Regulatory Affairs

　　1-3 years of experience in a related field

　　Employee Value Proposition (EVP):

　　As part of a rapidly growing medical device company, you'll be contributing to a team that aids individuals with severe injuries. You'll have the opportunity to help expand our product line across South America. Our office is located in a brand new, beautiful building in Miami, Florida, offering a flexible and modern work environment.

　　Work Environment:

　　Our team enjoys a professional office setting with state-of-the-art facilities, designed to foster productivity and collaboration.

　　Location:

　　Miami, Florida

　　Diversity, Equity & Inclusion

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.