Stryker

Stryker

Senior Regulatory Affairs Specialist (Hybrid)

Portage, Michigan, USA · Senior · Contract

Sponsorship not specified$83k-$139kDetected 1 day ago
ComplianceProduct ManagementFDA RegulatoryMedical DevicesCommunicationRegulatory Affairs

Stay score

odds of building a lasting career here

45Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role72
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 III · 3×
Level I$52,7491 entry
Level II$65,6862 entries
Level III$78,6453 entries
Level IV$91,5824 entries

$8,282 more — $91,582 — moves this role to Level IV and 4 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 $91,582 would place this position at wage Level IV. 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) · Kalamazoo-Portage, MI. 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: 55%

Of 11 labor certifications old enough to have been used, 5 expired without the employer filing the next step. Median time from filing to decision: 508 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

  • Work Flexibility: Hybrid Stryker is hiring a Senior Regulatory Affairs Specialist for our Instruments/Neurosurgical division.
  • This is a hybrid position based two to three days per week onsite in Portage, MI.
  • The role provides exposure to regulatory authorities, market access activities, product changes, audits, and post-market compliance.

Responsibilities

  • Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations.
  • Partner with Product Development, Quality, Marketing, and other stakeholders to integrate regulatory requirements into product development, commercialization, and lifecycle activities.
  • Support regulatory inspections and audits, develop regulatory procedures and standard operating procedures, and train stakeholders on new or changing regulatory requirements.
  • Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
  • As the Senior Regulatory Affairs Specialist, you will work across functions to develop regulatory strategies, prepare submissions, maintain product registrations, and interpret evolving global regulatory requirements.

Requirements

  • Maintain post-market regulatory compliance by supporting safety reporting, product recalls, post-market commitments, required reports, and communications with regulatory authorities.
  • Bachelor's degree in Engineering, Science, Life Sciences, or a related discipline
  • Minimum 2 years of experience in Regulatory Affairs or a related regulatory discipline within a regulated industry.
  • Master's degree in Regulatory Science or Regulatory Affairs Certification (RAC)

Compensation

  • Prepare and submit regulatory documentation, including product registrations, annual licenses, listings, supplemental dossiers, and notifiable changes to applicable regulatory authorities.
  • USN: $83,300 - $138,800 USD Annual

Benefits

  • Experience in the medical device industry
  • Stryker is an EO employer - M/F/Veteran/Disability.

Equal opportunity

  • Stryker Corporation is an equal opportunity employer.
  • Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

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