Regulatory Affairs Specialist (510(k))

Job Description

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'll Do

• 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

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 change at any time, with or without notice, based on business needs.