Regulatory Operations Specialist

The Opportunity

Regulatory Operations owns the "how" of regulatory work — the systems, data, publishing pipeline, and registry interfaces that let RA Specialists focus on strategy, dossier content, and agency engagement. The Regulatory Operations Specialist is the hands-on execution role within that function: maintaining the registration data everything else depends on, publishing and transmitting submissions to required standards, and keeping trackers, archives, and correspondence logs accurate and audit-ready. The role is expected to be the dependable operational backbone of the RA team.

What You'll Do

• Maintain the master registration matrix and renewal tracker (license/registration data, classifications, license holder, expiry dates, certificate links), updating weekly from RA Specialists, contractors, and ARs.
• Maintain the product-country crosswalk and reconcile the matrix against the QMS controlled-document index; prepare inputs for the monthly RegOps status report.
• Compile submission packages from controlled documents, CER/CEP, labeling, and risk file; apply the BSI publishing standard and validate against country-specific specs (eSTAR for FDA, MDR Annex II/III for BSI, and equivalent).
• Submit through agency portals, capture receipts, and maintain the submission and deficiency trackers and 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 using the registration matrix and significant-change rules library; 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).

Required Knowledge, Skills And Abilities

• 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.