Regulatory Operations Specialist

Caldera Medical; Westlake Village (CA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical and Dental Benefits for员工 and家

Vision Coverage

401(k) with 4% matching contributions

Basic Life and AD&D

Unlimited Vacation Policy

6 Weeks Paid Maternity Leave

10 paid holidays

Being surrounded by amazing people

Job summary

Caldera Medical in Westlake Village, CA is seeking a Regulatory Operations Specialist to maintain registration data, publish submissions, and manage trackers and logs for audit readiness.

You will handle submission packages, portal submissions, and keep records in major regulatory portals, supporting RA strategy and agency engagement.

Qualifications

• 1–3 years in regulatory operations, regulatory affairs, document control, quality, or related medical device function.
• 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).
• Process discipline; works reliably to SOPs, templates, and checklists.
• Cross-functional reliability; partner to RA, QA, and external ARs.
• Ownership mindset; treat registry records and submissions with accuracy.
• Able to work on-site at Westlake Village, CA headquarters.
• Bachelor's degree in a scientific, technical, or related discipline.

Responsibilities

• Maintain the master registration matrix and renewal tracker (license/registration data, classifications, license holder, expiry dates, certificate links).
• Maintain the product-country crosswalk and reconcile the matrix against the QMS controlled-document index; prepare inputs for monthly RegOps status report.
• Compile submission packages from controlled documents, CER/CEP, labeling, and risk file; apply publishing standards and validate against country specs (FDA eSTAR, MDR Annex II/III).
• Submit through agency portals, capture receipts, and maintain submission and deficiency trackers and archive.
• Enter and refresh records in EUDAMED, FDA GUDID, Swissmedic, and country portals; maintain 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 dossiers post-implementation.
• Maintain 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).

Skills

Data discipline

Portal fluency

Regulatory operations literacy

Process discipline

Cross‑functional reliability

Ownership mindset

Attention to detail

Team collaboration

Education

Bachelor's degree in scientific/technical discipline

Tools

Acrobat

OCR utilities

Validation tools

Job description

Regulatory Operations Specialist

**on site in Westlake Village, CA - no remote option**

Caldera Medical’s Mission - To Improve the Quality of Life for Women!

About Caldera Medical

Caldera Medical is committed to improving the quality of life for women worldwide through innovative, minimally invasive pelvic health solutions. Our Regulatory Affairs team keeps that mission moving — maintaining the registrations, submissions, and agency relationships that keep our products available to the clinicians and patients who rely on them.

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.

Competitive Compensation, Comprehensive Benefits, and more!

• Medical and Dental Benefits for employee and family members
• Vision Coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 10 paid holidays
• Being surrounded by amazing people!

(This role is being filled directly by our in‑house recruiting team. We are not working with outside agencies for this position.)

Our Culture- Where Career and Passion come together!

• A Culture of family and team… not a corporate goliath where you’re just another number.
• All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women's Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Who is Caldera Medical?

Caldera Medical is dedicated to improving the quality of life for women through innovative surgical solutions for stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids.

Our products are trusted by surgeons worldwide, and our commitment extends beyond medical advancements. We foster strong partnerships with surgeons and lead the largest humanitarian program in women's health, aiming to provide treatment to one million underserved women by 2027.

Guided by integrity, we prioritize patients, customers, employees, and the community over profit. As the fastest-growing women's health company, we remain committed to expanding education and access to life‑changing care for women everywhere.

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.