Regulatory Affairs Specialist

Regulatory Affairs Specialist The Regulatory Affairs Specialist plays a key role in maintaining regulatory compliance for a growing medical device organization. This individual develops and implements regulatory policies and procedures that meet the requirements of the countries where products are distributed, with a strong focus on medical devices. The role works proactively and collaboratively with Marketing, Sales, Operations, Quality, Engineering, and R&D to support successful regulatory submissions, approvals, and ongoing compliance. Responsibilities Direct coordination and preparation of document packages for regulatory submissions from all areas of the company, including internal audits and inspections. Prepare and manage 510(k) and PMA submissions for the FDA, ensuring completeness, accuracy, and timely delivery. Create and maintain Technical Documentation for Europe, including Technical Files and Design Dossiers for medical devices. Manage regulatory-related projects, including the implementation of new standards and regulations across the organization. Oversee Adverse Event reporting for the United States and Vigilance Reporting for markets outside the United States, ensuring compliance with applicable regulatory requirements. Manage device registration activities in all markets where products are sold. Recommend changes to labeling, manufacturing processes, marketing materials, and clinical protocols to maintain and improve regulatory compliance. Coordinate activities and communications with regulatory agencies on defined matters, serving as a key point of contact. Collaborate with R&D to develop strategies that support the earliest possible approvals of clinical trial applications and regulatory submissions. Stay current with regulatory procedures and developments in regulatory affairs to anticipate changes and advise internal stakeholders. Support document control activities related to regulatory documentation to ensure accurate, organized, and auditable records. Essential Skills Bachelor’s degree in Engineering or Regulatory Affairs. 1–3 years of experience in regulatory affairs or a closely related field, preferably in the medical device industry. Strong technical writing skills, with the ability to produce clear, accurate, and compliant regulatory documents. Knowledge of FDA regulations and processes, including experience with 510(k) and PMA submissions. Understanding of regulatory requirements for medical devices in the United States and international markets, including Europe. Experience with adverse event and vigilance reporting requirements. Ability to manage multiple regulatory projects and deadlines while maintaining attention to detail. Strong organizational skills for compiling, maintaining, and controlling regulatory documentation. Ability to build collaborative relationships with cross‑functional teams such as Marketing, Sales, Operations, Quality, Engineering, and R&D. 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. 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) Work Environment This role is based in an office setting within modern, well‑appointed facilities. The organization operates across two nearby locations, including a high‑rise building housing the Quality team and a two‑story building that includes a surgery center on the first floor and the design team on the second floor. The company is a growing medical device organization with approximately 40 team members and a track record of consistent year‑over‑year growth. The work environment offers a brand‑new, beautiful office space, a collaborative atmosphere, and a high degree of flexibility. The team focuses on developing devices that help individuals who are severely injured and is actively expanding its product line across South America. Job Type & Location This is a Contract to Hire position based out of Miami, FL. Equal Opportunity Employer 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, please email View email address on click.appcast.io for other accommodation options. #J-18808-Ljbffr