Principal Regulatory Affairs Specialist

Position Type and Expected Hours of Work

Full-Time, Monday-Friday, 40 hours/week

Elucent Medical isa medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.

The Principal Regulatory Affairs Specialist applies advanced, specialized knowledge of U.S. FDA medical device regulations, FDA guidance documents, 21 CFR Parts 807, 801, 820/QMSR, and 830, ISO 13485, ISO 14971, and other applicable standards to execute regulatory strategies, submissions, and lifecycle compliance activities for new and modified Class I and Class II medical devices. This is an individual contributor role focused on hands‑on execution of U.S. regulatory activities under the direction of the Regulatory Affairs Director.

The role requires direct experience preparing and supporting FDA 510(k) s, pre-submissions/Q-submissions, letters to file, regulatory assessments, FDA question responses, and other regulatory documentation. Working knowledge of EU MDR and other international regulatory frameworks is preferred, but the core emphasis of this position is U.S. FDA regulatory execution, 510(k) submission support, and ongoing FDA compliance.

The Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post‑market activities.

The position requires strong regulatory judgment, technical writing, project execution, and the ability to work effectively with cross‑functional teams while maintaining compliance throughout the product lifecycle.

No direct supervisory responsibilities. This position is an individual contributor role. May mentor and provide technical guidance to regulatory affairs team members and cross‑functional project teams as requested but does not manage personnel or assign departmental resources.

Execute U.S. regulatory strategies and deliverables for new product development, product modifications, and sustaining activities for medical devices, with emphasis on FDA 510(k) pathways and related FDA interactions.

• Prepare, coordinate, compile, and support submission of high‑quality FDA regulatory submissions, including 510(k) s, pre‑submissions/Q‑submissions, letters to file, and other FDA correspondence as directed.
• Serve as a regulatory affairs representative on cross‑functional project teams, providing regulatory input in product development, design control, manufacturing, quality, clinical, labeling, software, and commercialization discussions.
• Independently assess product, design, manufacturing, labeling, software, supplier, and process changes for regulatory impact and document whether FDA submissions, internal documentation, or other actions are required.
• Support FDA communications by preparing meeting materials, draft responses to FDA questions, interactive review responses and deficiency responses.

• Prepare accurate, complete, and timely FDA 510(k) submission content and related FDA communications in alignment with the associated regulatory strategy.
• Execute documented U.S. regulatory strategies for new products, product modifications, and sustaining changes.
• Identify regulatory obstacles, elevate risks appropriately, and recommend practical execution options to minimize clearance or implementation delays.

• Perform formal regulatory impact assessments for design, labeling, software, manufacturing, supplier, and process changes.
• Support post‑market regulatory…