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Regulatory Affairs Lead k) Medical Devices; On-Site

Job in Blue Ash, Hamilton County, Ohio, USA
Listing for: Vein360
Full Time position
Listed on 2026-10-07
Job specializations:
  • Healthcare
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 80000 - 105000 USD Yearly USD 80000.00 105000.00 YEAR
Job Description & How to Apply Below
Position: Regulatory Affairs Lead, 510(k) for Medical Devices (On-Site)

Vein
360 in Cincinnati, OH is seeking a Regulatory Affairs Specialist to own the 510(k) regulatory path from strategy through FDA clearance. This hands-on role requires practical regulatory judgment and the ability to drive submissions in a fast-paced, small-team environment.

You will lead end-to-end filings, coordinate with Engineering, Quality, and Operations, respond to FDA questions, and shape submission strategies to keep the pipeline moving on schedule.

We are currently recruiting a Regulatory Affairs Lead, 510(k) for Medical Devices (On-Site) for our team in Blue Ash, OH, United States.

Step into the Regulatory Affairs Lead, 510(k) for Medical Devices (On-Site) role at Vein
360 in Blue Ash, OH, United States and grow with us.

Please review the full job details above before applying.

If your experience matches this role, we encourage you to apply.

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