Regulatory Affairs Specialist

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

About the Role

Own the regulatory path that brings restored medical devices to market. You'll be the hands-on regulatory owner, driving 510(k) submissions from strategy through FDA clearance in a lean, fast-moving environment. This position is based full-time at our Cincinnati, OH facility and reports to the COO or designee.

Success in this role means clearances move forward on schedule and internal teams get the practical regulatory direction they need to keep moving.

Responsibilities

• Lead 510(k) submissions end-to-end: from regulatory strategy and planning through filing, FDA interaction, deficiency responses, and clearance
• Develop and defend predicate-device and substantial-equivalence strategies, translating regulatory requirements into clear evidence, testing, labeling, and documentation needs
• Own FDA correspondence and submission follow-up, delivering prompt, well-supported responses to review questions and requests for additional information
• Partner directly with Engineering, Quality, Operations, and validation/testing resources to solve practical product and reprocessing challenges without compromising regulatory rigor
• Maintain submission plans, records, and decision rationales; identify risks early and improve regulatory processes to keep a small team executing efficiently

Requirements

• 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.