Regulatory Affairs Specialist (510(k))

Vein360; Blue Ash (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Vein360 is seeking a Regulatory Affairs Specialist to own the 510(k) regulatory path from strategy through FDA clearance. This full-time, on-site role in Cincinnati requires hands-on experience leading 510(k) submissions and strong knowledge of U.S. regulatory expectations.

You will collaborate with design, QA, and operations to assemble complete submission packages and respond quickly to FDA questions, driving timely clearances in a lean environment.

Qualifications

• 3+ years of hands-on regulatory affairs in medical devices.
• Direct ownership of one or more 510(k) submissions through FDA clearance.
• Experience preparing, filing, and managing FDA 510(k) submissions and related docs.
• Strong knowledge of U.S. medical-device regulatory expectations.
• Ability to translate regulatory requirements into design/test/quality documentation.
• Experience responding to FDA questions with evidence-based actions.
• Cross-functional collaboration in a lean, small team.

Responsibilities

• Own the 510(k) submission process from strategy to FDA clearance.
• Coordinate with design, QA, and operations to assemble complete packages.
• Defend regulatory positions during FDA review cycles with data.

Skills

510(k) Submissions

FDA Regulatory

Regulatory Affairs

Cross-functional

Regulatory Strategy

Documentation

Education

RAC Certification

Job description

Regulatory Affairs Specialist (510(k))

Location: Cincinnati, OH (100% On-Site)

Own the regulatory path that brings restored medical devices to market.

Vein360 is looking for a Regulatory Affairs Specialist to serve as our hands‑on regulatory owner, driving 510(k) submissions from strategy through FDA clearance. This is a high‑impact role for someone who combines strong FDA submission experience with practical judgment, persistence, and the ability to solve real‑world problems in a lean, fast‑moving environment.

This position is based full‑time at our Cincinnati, OH facility. It is not eligible for remote or hybrid work.

Reports to: COO or designee

Why This Role Matters

You’ll be the driving force behind our 510(k) pipeline–managing it proactively, building submission packages that are complete and technically defensible, and getting FDA questions answered quickly and effectively. Success in this role means clearances move forward on schedule and internal teams get the practical regulatory direction they need to keep moving.

What You Bring

• Minimum 3 years of hands‑on Regulatory Affairs experience in medical devices
• Direct experience personally leading or materially owning one or more 510(k) submissions through FDA clearance; not just providing peripheral support
• Hands‑on ability to prepare, assemble, file, and manage FDA 510(k) submissions, including substantial‑equivalence rationale, predicate strategy, labeling, and supporting technical documentation
• Strong working knowledge of U.S. medical‑device regulatory expectations, with the ability to translate them into concrete requirements for design, testing/validation, and quality documentation
• Demonstrated skill responding to FDA review questions and deficiencies with clear, evidence‑based arguments and practical corrective actions
• Experience working cross‑functionally with technical and quality teams, with enough independence to operate effectively in a small organization
• Adaptable and creative within regulatory boundaries, with the tenacity to challenge assumptions and defend a sound position through difficult review cycles
• A hard‑working, accountable, and pragmatic problem‑solver comfortable making decisions with limited resources

Nice to Have

• Experience with single‑use device (SUD) reprocessing or another medical‑device reprocessing business model
• Experience with reprocessing‑related technical evidence such as cleaning, disinfection/sterilization, functional/performance validation, biocompatibility, or packaging validation
• Background in Class II / 510(k)-heavy device portfolios, regulatory consulting with direct submission ownership, or a combined Regulatory/Quality role in a lean organization
• Regulatory Affairs Certification (RAC) or a relevant technical/scientific degree

Why Join Vein360

You’ll take ownership of a real regulatory pipeline from day one, working closely with cross‑functional leaders in a lean, high‑accountability environment where your judgment and follow‑through directly drive clearances — and the company’s growth.

Equal Employment Opportunity Statement

Vein360 is an Equal Opportunity Employer. Employment decisions are based on business needs, job requirements, and individual qualifications. Vein360 does not discriminate on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law.

Vein360 is committed to providing reasonable accommodations to qualified individuals with disabilities in the application process and throughout employment, as required by applicable law.

Disclaimer

This job description and above statements are intended to describe the general nature and level of work performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, qualifications, or working conditions. Duties, responsibilities, and activities may be changed at any time, with or without notice, based on business needs.