Regulatory Affairs Specialist (510(k))

Vein360•Blue Ash, OH

1d•Onsite

About The Position

Vein360 is seeking a Regulatory Affairs Specialist to be the primary owner of the regulatory path for bringing restored medical devices to market. This role will drive 510(k) submissions from strategy through FDA clearance. The ideal candidate will possess strong FDA submission experience, practical judgment, persistence, and the ability to solve problems in a fast-paced, lean environment. This is a full-time, on-site position at the Cincinnati, OH facility.

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.
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 and ability to translate them into concrete requirements for design, testing/validation, and quality documentation.
Demonstrated skill in 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 independence to operate effectively in a small organization.
Adaptable and creative within regulatory boundaries, with tenacity to challenge assumptions and defend sound positions.
A hard-working, accountable, and pragmatic problem-solver comfortable making decisions with limited resources.

Nice To Haves

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.

Responsibilities

Lead 510(k) submissions end-to-end, including regulatory strategy, planning, filing, FDA interaction, deficiency responses, and clearance.
Develop and defend predicate-device and substantial-equivalence strategies, translating regulatory requirements into evidence, testing, labeling, and documentation needs.
Manage FDA correspondence and submission follow-up, providing prompt and well-supported responses to review questions and requests for additional information.
Collaborate with Engineering, Quality, Operations, and validation/testing resources to address product and reprocessing challenges while maintaining regulatory rigor.
Maintain submission plans, records, and decision rationales.
Identify risks early and improve regulatory processes for efficient execution in a small team.