Regulatory Operations Specialist

Caldera Medical•Westlake Village, CA

4d•Onsite

About The Position

Caldera Medical's mission is to improve the quality of life for women worldwide through innovative, minimally invasive pelvic health solutions. The Regulatory Affairs team supports this mission by maintaining registrations, submissions, and agency relationships. The Regulatory Operations function focuses on the systems, data, publishing pipeline, and registry interfaces that enable the Regulatory Affairs team to concentrate on strategy and dossier content. The Regulatory Operations Specialist is a hands-on role responsible for maintaining registration data, publishing and transmitting submissions, and ensuring trackers, archives, and correspondence logs are accurate and audit-ready. This role serves as the operational backbone of the Regulatory Affairs team.

Requirements

1–3 years in regulatory operations, regulatory affairs, document control, quality, or a related medical device function — or a strong adjacent data/administrative role with regulatory exposure.
Data discipline and attention to detail — comfortable owning and reconciling large trackers and spreadsheets (advanced Excel).
Regulatory operations literacy — understands submission structure and controlled-document management.
Portal fluency — comfortable in regulator portals (EUDAMED, GUDID, country portals), or clear aptitude to learn them quickly.
Process discipline — works reliably to defined SOPs, templates, and checklists; escalates rather than works around problems.
Cross-functional reliability — a prepared, trustworthy partner to RA, QA, and external ARs.
Ownership mindset — treats registry records and submissions with the accuracy the patient-facing stakes require.
Able to work on-site at Westlake Village, CA headquarters.
Bachelor's degree in a scientific, technical, or related discipline, or equivalent experience.

Responsibilities

Maintain the master registration matrix and renewal tracker, updating weekly.
Maintain the product-country crosswalk and reconcile the matrix against the QMS controlled-document index.
Compile submission packages from controlled documents, CER/CEP, labeling, and risk file.
Apply the BSI publishing standard and validate against country-specific specs.
Submit through agency portals, capture receipts, and maintain submission and deficiency trackers.
Maintain a standardized submission archive.
Enter and refresh records in EUDAMED, FDA GUDID, Swissmedic, and country registry portals.
Maintain the portal credentials log and registry-to-RIM crosswalk.
Support quarterly data audits comparing registry records against controlled label, IFU, and DHF.
Log and drive correction of discrepancies.
Support market-by-market change impact assessments.
Verify affected dossiers/registries post-implementation.
Maintain the regulator correspondence log, records archive/retention schedule, and open-items/commitment tracker.
Maintain version control of the template and SOP library.
Coordinate labeling/translation vendor logistics.
Manage day-to-day access to the regulatory tool stack (Acrobat, OCR utilities, validation tools, portal provisioning).