Penumbra

Penumbra

Regulatory Affairs Specialist I

Alameda, CA

Sponsorship not specified$77k-$98kDetected 39 days ago
ExcelIntellectual PropertyFDA RegulatoryMedical DevicesResearchCommunicationMicrosoft OfficeRegulatory Affairs

Stay score

odds of building a lasting career here

50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

Personalize to your clock →

H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level I · 1×
Level I$73,5701 entry
Level II$97,7392 entries
Level III$121,8883 entries
Level IV$146,0584 entries

$20,739 more — $97,739 — moves this role to Level II and 2 lottery entries. That figure is inside the range the employer already advertised.

Based on the DOL prevailing wage for this occupation and worksite, a base salary of $97,739 would place this position at wage Level II. That figure is within the posted range, and I'd like to target it. This role classifies under "Compliance Officers" for prevailing-wage purposes.

DOL prevailing wage, 2026-27 wage year · Compliance Officers (13-1041) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

Employer immigration record

from this employer's Department of Labor filings

Green-card follow-through: 78%

Of 9 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 491 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

8 transfer filings in the last year, covering 8 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

Community outcomes

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About the role

  • In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide.
  • Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.

Responsibilities

  • Support in-country RA personnel to facilitate global clearance/approvals.
  • Support labeling reviews (e.g., Instructions for Use and product labels).
  • Train in existing systems, Work Instructions, and SOPs as needed to support departmental functions and the Quality System.
  • Understand Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements
  • Support Regulatory change assessment for product changes.

Requirements

  • Willingness and ability to work on site as needed.

Compensation

  • $77,000 - $98,000 / year We offer a competitive compensation package plus a benefits and equity program, when applicable.
  • Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Benefits

  • A Bachelor's degree in a relevant discipline or an equivalent combination of education and or demonstrated experience
  • Regulatory Medical Device experience preferred

Equal opportunity

  • For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.

This listing is sourced directly from Penumbra's careers page and normalized into a canonical job model.