New · posted Oct 19
Stryker · Medical Devices
Staff Regulatory Affairs Specialist, Mako and Enabling Technologies
- Remote, US
- Remote
- Full-time
- Senior & Principal
Open until filled
The role
Work Flexibility: Remote
Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)
Join Stryker’s Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets.
Work Flexibility:
This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone
What you need
Required Qualifications
- Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related field.
- Minimum 4 years of experience in an FDA-regulated industry.
- Minimum 3 years of Regulatory Affairs experience.
- Experience preparing regulatory submissions for product approvals.
Preferred Qualificationsnice to have
- Regulatory Affairs Certification (RAC) and/or Master’s degree in Regulatory Affairs or a related field.
- Experience supporting Class II and/or Class III medical devices.
- Experience authoring FDA 510(k) submissions.
- Experience interacting directly with regulatory agencies and notified bodies.
What you'll do
- Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities.
- Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases.
- Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies.
- Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals.
- Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance.
- Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities.
- Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications.
- Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory processes and best practices.
Pay
$77,700 – $207,400 a year
Employer providedUnited States of America Pay Ranges
- Puerto Rico: $77,700 - $129,500 USD Annual
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 USD Annual
- US30: $124,400 - $207,400 USD Annual
Equal opportunity, accessibility and legal noticesStryker's statements, word for word
View the U.S. work location and transparency guide to find the pay range for your location.Travel Percentage: NoneStryker 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 4% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in New Jersey10 roles publishing pay
Senior & Principal roles in the US56 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $77,700 | — | $207,400 |
| New Jersey (middle half) | $142,625 | $149,750 | $176,500 |
| All US (middle half) | $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.
Skills DNA
What this role leans on
How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Collaboration and leadership4
- GMP and compliance3
- Documentation and SOPs2
- Data and digital systems1
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.
From Regulatory News
Manufacturing and quality coverage for this professionCompany 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%
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Staff Regulatory Affairs Specialist, Mako and Enabling Technologies at Stryker
Open until filled. $78K–$207K a year, employer provided.