Regulatory Affairs Specialist

Job Title:

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.

+ Create and maintain EU Technical Documentation for medical devices for regulatory purposes, ensuring alignment with current regulations.

+ Compile all materials required for regulatory submissions, license renewals, and annual registrations.

+ 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.

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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.

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.

Pay and Benefits

The pay range for this position is $33.65 - $38.46/hr.

Eligibility requirements apply to some benefits and…