Clinical Regulatory Specialist

Location: Eagleville

Job Title:

Clinical Regulatory Specialist

Job Description

The Clinical Regulatory Specialist supports the development, preparation, and submission of U.S. regulatory filings for Class II and Class III medical devices. This role partners closely with Product Development, Clinical Affairs, and other internal teams to prepare and review 510(k) submissions, coordinate supporting documentation, obtain final approvals, and respond to FDA requests. The Specialist assists with IDE and PMA submissions, contributes to nonclinical, manufacturing, and clinical sections of PMA packages, reviews clinical study data for regulatory reporting, and supports the ongoing maintenance of approved PMAs.

Responsibilities

+ Support the preparation, review, and submission of U.S. medical device regulatory filings, with a focus on 510(k) submissions and FDA Pre-Submissions.

+ Partner with Product Development, Clinical Affairs, and other internal teams to gather information, prepare submission content, and coordinate supporting documentation.

+ Prepare final regulatory submission packages and assist in responding to FDA questions and requests for additional information.

+ Assist with IDE and PMA submissions, including drafting and assembling nonclinical, manufacturing, and clinical sections of PMA packages.

+ Review clinical study data, manufacturing information, and nonclinical documentation as needed to support regulatory reporting and submissions.

+ Support the ongoing maintenance of approved PMAs, including PMA supplements, annual reports, and other post-approval activities.

+ Evaluate the regulatory impact of product, manufacturing, design, and process changes, applying sound regulatory judgment and departmental guidelines.

+ Review Document Change Orders, drawings, labeling changes, Regulatory Pathway Forms, and supporting documentation to determine appropriate regulatory pathways.

+ Review labeling, promotional materials, and other controlled product documentation to ensure regulatory compliance and alignment with FDA requirements.

+ Review and maintain Note-to-File documentation and other records to ensure documentation is accurate, complete, and compliant.

+ Contribute to the development and refinement of Regulatory Standard Operating Procedures (SOPs) as needed.

+ Collaborate cross-functionally with Product Development, Clinical Affairs, management, and other internal groups to obtain information required for submissions.

+ Manage multiple projects and priorities simultaneously, using strong organization and time-management skills to meet deadlines.

+ Document regulatory decisions clearly and maintain high standards of attention to detail and document management.

+ Participate in training and knowledge-sharing activities, and when applicable, help train new team members on Regulatory processes.

Essential Skills

+ Approximately 2 to 5 years of Regulatory Affairs experience in the medical device industry.

+ Direct experience supporting U.S. medical device submissions, particularly 510(k) s and FDA Pre-Submissions.

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Experience with medical device development and product registration.

+ Knowledge of U.S. medical device submission requirements, including 510(k) processes and FDA interactions.

+ Experience evaluating the regulatory impact of product, manufacturing, design, or process changes.

+ Experience reviewing labeling, promotional materials, and other controlled product documentation for regulatory compliance.

+ Ability to review clinical, manufacturing, and nonclinical information for regulatory submissions.

+ Familiarity with FDA regulations, applicable guidance documents, and Title 21 of the Code of Federal Regulations.

+ Ability to understand technical products, product changes, and supporting documentation.

+ Strong written and verbal communication skills.

+ Excellent attention to detail and document-management skills.

+ Ability to work independently while contributing effectively within a cross-functional team.

+ Strong time-management skills with the ability to manage multiple projects and changing priorities.

+ Proficiency with Microsoft Word, Excel, PowerPoint, and Teams.

+ Positive, professional, and responsive approach, with the ability to build productive working relationships.

Additional

Skills & Qualifications

+ Bachelors degree in a health, science, engineering, or related technical field; an engineering degree is preferred.

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Experience with Class II or Class III medical devices is preferred but not required.

+ Orthopedic medical device experience is…