Principal Regulatory Affairs Specialist

Elucent Medical•Eden Prairie, MN

5d•Hybrid

About The Position

Elucent Medical is a 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.

Requirements

A minimum of a bachelor's degree in a scientific discipline (biochemistry, biology, chemistry, etc.) or engineering discipline (mechanical, biomedical, chemical, electrical, software, etc.).
Minimum of 7 years of direct medical device Regulatory Affairs experience; or minimum of 5 years of direct medical device Regulatory Affairs experience with an advanced degree in a related discipline.
Direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.
Demonstrated experience supporting direct FDA interactions, such as pre-submissions/Q-submissions, interactive review, deficiency responses, meeting preparation, or regulatory correspondence.
Demonstrated ability to author, compile, and manage 510(k) submission content, support FDA questions, and contribute to successful clearance of Class II medical devices.
Experience serving as a key regulatory contributor in communications with FDA reviewers, including Q-submissions, interactive review, deficiency responses, and meeting preparation.
Advanced knowledge of FDA medical device requirements, including establishment registration, device listing, GUDID/UDI, labeling, quality system, and post-market obligations.
Ability to execute regulatory strategies, assess submission requirements, evaluate predicate documentation, and prepare compliant implementation plans.
Ability to conduct formal assessments for design, manufacturing, labeling, software, process, supplier, and site changes and determine required regulatory actions.
Ability to write clear, accurate, and well-structured regulatory submissions, technical summaries, response letters, regulatory assessments, and internal decision documentation.
Ability to work effectively with R&D, Quality, Manufacturing, Clinical, Marketing, Operations, and leadership stakeholders to complete regulatory deliverables and communicate regulatory requirements and risks.
Ability to create regulatory work plans, manage submission tasks and timelines, prioritize multiple projects, and drive assigned deliverables to completion in a fast-paced environment.
Ability to identify regulatory obstacles, assess regulatory risks, recommend pragmatic solutions, and escalate issues requiring strategic decision-making.
Experience interpreting FDA guidance documents, recognized consensus standards, ISO 14971, IEC 62304, IEC 60601, and other applicable standards.
Strong verbal and written communication skills with the ability to explain complex regulatory topics clearly across multiple organizational levels.
Ability to maintain accurate regulatory files, organize complex technical documentation, and ensure submissions are complete and inspection-ready.
Commitment to regulatory compliance, data integrity, and ethical decision-making in all regulatory activities.

Nice To Haves

Working knowledge of EU MDR and other international regulatory frameworks is preferred.
Master's degree in Regulatory Affairs or related scientific/engineering discipline
Regulatory Affairs Certification (RAC) is a plus.
Familiarity with EU MDR technical documentation, ISO standards, and OUS registration support is preferred but secondary to U.S. FDA regulatory expertise.

Responsibilities

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, escalate 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 compliance, including field actions, recalls, and required FDA communications, under the direction of regulatory affairs leadership.
Act as a core regulatory affairs contributor for development and manufacturing teams.
Translate FDA requirements into actionable deliverables for R&D, Quality, Manufacturing, Clinical, Marketing, and Operations stakeholders.
Drive assigned regulatory deliverables across multiple projects while maintaining alignment with quality and business objectives.
Maintain regulatory activities in alignment with the Quality Policy, QMS procedures, and applicable FDA and ISO requirements.
Identify opportunities to improve regulatory processes, templates, submission quality, and documentation efficiency.
Support audits, CAPAs, SOP updates, and continuous improvement initiatives as a regulatory subject matter contributor.
Develop processes and controls to monitor device performance, reliability and create projects to track improvement initiatives.
Work with, and advise, the R&D and Quality teams in trends in reliability and areas to focus improvement.
Work with field and project teams to prioritize new product initiatives to expand our customer configurations.