Glaukos Corporation
Sr. Regulatory Affairs Specialist
Burlington, MA, United States · Senior
Stay score
odds of building a lasting career here
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
$12,735 more — $110,635 — moves this role to Level III and 3 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 $110,635 would place this position at wage Level III. 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) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- RA Specialist is Responsible for preparation of regulatory submissions (domestic and foreign).
- Ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal SOPs.
- RA Specialist is responsible for preparation of regulatory submissions (primarily domestic).
Responsibilities
- Document legalization
- Support international registrations as requested
- Internal review of labeling, advertising, and document change orders as needed
- Maintain regulatory files and associated spreadsheets, reports, documents
- Participate in company training programs that maintain appropriate awareness and compliance with ISO and CFR requirements
- Interact and coordinate with R/D staff to ensure compliance with applicable Design Control Requirements.
Requirements
- Assists with preparation of 510(k), IDE's, PMA regulatory submissions required by FDA
- Prepare and maintain required materials including but not limited to:
Nice to have
- Field action support (documentation generation, shipment, customer contact, required reporting, effectiveness, follow-up, closeout)
- Interact and coordinate with Clinical staff to facilitate clinical studies regulatory compliance.
- Knowledge of FDA guidelines for regulatory submissions and correspondence and detailed knowledge electronic submission requirements.
- Experience with combination products is a plus.
Skills
- Team Player, adaptability, hand-on minded, problem solving minded
- Critical thinking, ability to determine root cause, to generate multiple solutions
- Well organized, self-motivated and dependable
- Open to directions and constructive feed-back
- Proficient in MS Word and Adobe Acrobat
- Good communication skills
- Minimum of Bachelor's Degree in combination with a minimum of 5 years of Regulatory Affairs Experience in industry is required.
- Experience in Ophthalmology is a plus.
- This role works onsite in our Burlington, MA offices
- Flexibility on salary range for the right experience
- Hybrid
- M-W-F onsite
Compensation
- 97,900.00 - 122,400.00 plus bonus and many other fantastic benefits and perks
- Flexibility on salary range for the right experience
- Support recurring US regulatory reports/requirements (e.g. PMA annual reports)
- Research scientific and regulatory information in order to write, edit, and review reports. Compile materials required for submissions, license renewals, and annual registrations
Benefits
- 5-7+ years of experience with preparing medical device regulatory submissions, including but not limited to IDE, PMA, 510 (k), etc.
This listing is sourced directly from Glaukos Corporation's careers page and normalized into a canonical job model.