Find & Apply For Regulatory Affairs Specialist Jobs in Irvine, California

Company Overview:

ACollaboratory America Inc., part of the global TSK Group of Companies, is a medical device company focused on innovative injection solutions that enhance practitioner performance and patient experience. As part of a growing global organization, ACollaboratory brings together science, engineering, clinical insight, and collaboration to advance injection technology and improve patient care. We operate in a fast-moving environment that values innovation, quality, collaboration, responsiveness, accountability, and continuous improvement.

SUMMARY:

We are seeking a Regulatory Affairs Specialist I with approximately three years of medical device regulatory experience to support product registrations, regulatory submissions, and ongoing registration maintenance. This is a practical, execution-focused role for someone who has personally worked in FDA FURLS/DRLM, contributed to FDA 510(k) submissions, and supported Canadian license updates or related regulatory maintenance activities. The successful candidate will independently manage routine assigned activities while working under the guidance of senior Regulatory Affairs staff on regulatory assessments and more complex submissions.

RESPONSIBILITIES

FDA Registration and Submission Support Maintain FDA establishment registrations and device listings in FURLS/DRLM, including annual renewals, new listings, and updates to existing records including GUDID. Verify registration and listing information against internal product records and applicable FDA clearance information. Support the preparation, compilation, and submission of FDA 510(k) applications, including organizing supporting documentation and completing assigned eSTAR sections. Support submission activities through the CDRH Portal, including tracking submission status and maintaining correspondence and acknowledgments. Coordinate information requests with Quality, R&D, Manufacturing, and other stakeholders to support submissions and responses to FDA questions. Canadian and International Registration Maintenance Support Health Canada medical device license applications, amendments, annual renewals, and related product or company information updates. Coordinate supporting documents with internal teams, regulatory representatives, and distributors. Assist with registrations, renewals, and updates in other assigned international markets. Maintain registration trackers, certificates, approved product lists, and submission records.

• Track upcoming deadlines and follow up on outstanding documents to support timely completion.
• Regulatory Documentation and Change Support
• Compile and maintain technical documentation and registration dossiers using approved templates and established procedures.

Support regulatory change assessments by gathering information on proposed products, labeling, manufacturing, or company changes for senior RA review. Review product identifiers, labeling, and submission documents for accuracy and consistency with approved regulatory records. Assist with regulatory research and summarize relevant requirements or changes for review. Maintain organized, traceable regulatory records and support audits or inspections as needed.

QUALIFICATIONS

• Bachelor's degree in life science, engineering, or related discipline.
• Approximately three years of regulatory affairs experience in the medical device industry.
• Direct experience using

FDA FURLS/DRLM

to enter, update, or maintain establishment registration and device listing information—not solely coordinating these activities through a consultant.

• Practical experience supporting at least one FDA 510(k) submission, with identifiable responsibility for preparing documentation, completing submission sections, or supporting electronic submission activities.
• Working experience supporting Canadian medical device license maintenance, amendments, renewals, or related updates.
• Working knowledge of medical device regulatory requirements and quality systems, including FDA requirements, EU MDR, and

ISO 13485.

• Strong attention to detail and the ability to maintain accurate product and registration data.
• Ability to manage multiple assigned tasks, follow established procedures, and meet deadlines.
• Clear written and verbal English communication skills.

DESIRED SKILLS AND EXPERIENCE

• Experience with FDA eSTAR and the CDRH Portal.
• Exposure to EU MDR technical documentation or international registration dossiers.
• Experience with needles, cannulas, syringes, or other sterile, single-use medical devices.
• Experience coordinating with international distributors, regulatory consultants, or in-country representatives.
• Experience reviewing labeling or supporting regulatory change-control activities.
• Additional language skills.

Pay:

$71,700.00 - $81,500.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person