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New · posted Oct 19

Stryker · Medical Devices

Senior Regulatory Affairs Specialist

  • Portage, MI
  • Hybrid
  • Full-time
  • Senior & Principal
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EmploymentFull-time
Deadline

Open until filled

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.

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. The role provides exposure to regulatory authorities, market access activities, product changes, audits, and post-market compliance.

What you need

Required

  • 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.
  • Experience preparing, coordinating, or executing regulatory submissions and related documentation.
  • Experience interpreting and applying regulatory requirements to product development, commercialization, or post-market activities.

Preferrednice to have

  • Master's degree in Regulatory Science or Regulatory Affairs Certification (RAC)
  • Experience in the medical device industry
  • Experience supporting product registrations, regulatory submissions, product changes, or post-market regulatory activities across multiple markets
  • Experience interacting with regulatory authorities or supporting regulatory inspections and audits
  • USN: $83,300 - $138,800 USD Annual

What you'll do

  1. Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations.
  2. Prepare and submit regulatory documentation, including product registrations, annual licenses, listings, supplemental dossiers, and notifiable changes to applicable regulatory authorities.
  3. Evaluate product and manufacturing changes for regulatory impact and recommend submission, approval, and compliance requirements throughout the product lifecycle.
  4. Maintain post-market regulatory compliance by supporting safety reporting, product recalls, post-market commitments, required reports, and communications with regulatory authorities.
  5. Review advertising, promotional materials, product labeling, and instructions for use to verify alignment with applicable regulatory requirements.
  6. Monitor regulatory intelligence and assess emerging requirements, risks, and market access considerations to inform local, regional, and global regulatory strategies.
  7. Partner with Product Development, Quality, Marketing, and other stakeholders to integrate regulatory requirements into product development, commercialization, and lifecycle activities.
  8. Support regulatory inspections and audits, develop regulatory procedures and standard operating procedures, and train stakeholders on new or changing regulatory requirements.

Pay

$83,300 – $138,800 a year

Employer provided
How this compares

Where you'll work

Portage, MIHybridOpen in Maps (opens in a new tab)

More jobs in Portage, MI
Equal opportunity, accessibility and legal noticesStryker's statements, word for word

Travel Percentage: 10%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. Stryker is an EO employer – M/F/Veteran/Disability.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. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Job intelligence

The context around this role

Live data · October 20, 2026

Salary intelligence

How the pay compares

This role's midpoint is 19% below the US median for Regulatory Affairs roles at this level.

This roleEmployer provided

$83,300 to $138,800 a year

Senior & Principal roles in the US56 roles publishing pay

Middle half $115,000 to $150,000, median $137,500
Annual base pay
Annual base payLowMedianHigh
This role$83,300—$138,800
All US$115,000$137,500$150,000

This role: Stryker's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Affairs

The general path across 302 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Stryker's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Regulatory Affairs Specialist · Summer 2027 Internship

    $92K median37 open
  2. This role

    Senior & Principal

    Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

    $138K median74 open
  3. Next step

    Manager

    Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

    $163K median63 open
  4. Later

    Director

    Often: Director, Regulatory Affairs · Senior Director, Regulatory Affairs

    $237K median111 open
  5. Later

    VP & Executive

    Often: Global Head of Injectable Aesthetics Regulatory Strategy · Global Head of Regulatory Affairs, Roche Diagnostics

    $323K median17 open

Skills DNA

What this role leans on

How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 6 linesLab testing and methods: 1 lineDocumentation and SOPs: 4 linesRegulatory submissions: 7 linesCollaboration and leadership: 3 linesGMPLab testingDocumentationSubmissionsTeamwork
  • Regulatory submissions7
  • GMP and compliance6
  • Documentation and SOPs4
  • Collaboration and leadership3
  • Lab testing and methods1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

Company hiring pulse

Stryker on Regulatory Jobs

62
Open roles
51
Distinct roles
18
Locations

By discipline

  • Quality49 79%
  • Regulatory11 18%
  • Compliance & Safety2 3%

By level

  • Senior & Principal36 58%
  • Associate & Specialist19 31%
  • Manager7 11%
See all 62 Stryker roles

More roles at Stryker

All 62 Stryker roles

Similar Regulatory Affairs roles elsewhere

Senior Regulatory Affairs Specialist at Stryker

Open until filled. $83K–$139K a year, employer provided.

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