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Medical Device Tracking Administrator Jobs (NOW HIRING)

Open Scientific

Regulatory Manager

Sunrise, FL · On-site

... commercial device tracking Develop clinical protocols and clinical study reports Prepare and submit medical device reports Perform various other duties as assigned Internal Networking/Key ...

Kellton Tech

Medical Device Quality Engineer

Madison, WI · On-site

$40 - $45/hr

Develop and maintain Quality System processes, including metrics reporting and tracking * Manage ... medical device experience preferred) Skills & Competencies: * Strong communication, coaching ...

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Infographic showing various Medical Device Tracking Administrator job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 86% Full Time, 10% Part Time, 1% Temporary, and 2% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution.

Regulatory Affairs Manager

Plantation, FL • On-site

Open Scientific
See more jobs at Open Scientificexternal

Full-time

Re-posted 3 days ago

Job description

Company Description
Headquartered in the U.S., our client is a division of a global company devoted to the research and development, manufacturing, and distribution of highly specialized products for Healthcare and Life Sciences worldwide.
This is a great step for someone who has progressed to a Manager level and wants to progress into a Director role in the future. If you are looking to take on a challenging role within a rapidly growing division that provides an A+ environment and excellent benefits, do not miss out on a potential opportunity to get your foot in the door.
Job Description
-Develop medical device regulatory submissions in accordance with FDA requirements (e.g., pre-submissions, original IDEs, IDE supplements, 6-month Investigator Lists, original PMAs, PMA supplements, IDE/PMA Annual Progress Reports, 510(k)s, MAFs)
-Develop Design Dossiers and Technical Files for CE marking purposes
-Develop other international regulatory submissions as required
-Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
-Review, edit and provide regulatory and quality system approval for project documentation.
-Review and analyze technical protocols, data, and reports generated by Research and Development, Operations, Clinical Research, Quality Assurance or other related departments.
-Participate in the development of world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
-Partner with cross functional teams by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.
-Develop procedures to ensure regulatory compliance
-Act as an active regulatory representative on project teams
-Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
-Review and provide regulatory authorization for Nonconformance reports (NCR)
-Provide Regulatory Affairs support during internal and external audits.
-Prepare and file facility registration documents
-Conduct external audit activities as requested
-Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA
-Manage commercial device tracking
-Develop clinical protocols and clinical study reports
-Prepare and submit medical device reports
-Perform various other duties as assigned
Qualifications
-Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required. Minimum 5 years direct experience in regulatory affairs (preferably in the medical device/drug or biomedical area).
-Solid knowledge of US and European regulatory processes, including Class III is required.
-Practical (hands-on) experience in a medical device regulatory environment, preparing submissions (IDEs/IDE supplements, PMAs/PMA Supplements, 510(k)s and Design Dossiers/Technical files) for Class II and III medical devices and a successful track record is required.
-Experience interacting with U.S. FDA and European Notified Bodies is required.
-Experience presenting at FDA meetings is preferred.
-Sound knowledge and understanding of how IDE-regulated clinical studies are performed is required.
-Experience in review and approval of promotional review process strongly preferred
-Comprehensive Knowledge of Design Control processes and controls
-Comprehensive Knowledge of Regulatory Standards needed in the medical device environment.
Please send suitable resumes in confidence to JPCuadra @ openscientific.com
Additional Information
All your information will be kept confidential according to EEO guidelines.

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