Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

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.

Job Responsibilities:

• 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.

Key Result Areas include:

• U.S. FDA Submissions and Regulatory Execution
• Regulatory Impact and Lifecycle Compliance
• Cross-Functional Regulatory Support
• Continuous Improvement

Qualifications:

• 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.
• Required: 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.
• Required: demonstrated experience supporting direct FDA interactions, such as pre-submissions/Q-submissions, interactive review, deficiency responses, meeting preparation, or regulatory correspondence.
• Preferred: Master's degree in Regulatory Affairs or related scientific/engineering discipline; Regulatory Affairs Certification (RAC) is a plus.

Required Skills/Abilities:

• FDA 510(k) Execution: Demonstrated ability to author, compile, and manage 510(k) submission content, support FDA questions, and contribute to successful clearance of Class II medical devices.
• FDA Interaction: Experience serving as a key regulatory contributor in communications with FDA reviewers, including Q-submissions, interactive review, deficiency responses, and meeting preparation.
• U.S. Regulatory Requirements: Advanced knowledge of FDA medical device requirements, including establishment registration, device listing, GUDID/UDI, labeling, quality system, and post-market obligations.
• Regulatory Strategy Implementation: Ability to execute regulatory strategies, assess submission requirements, evaluate predicate documentation, and prepare compliant implementation plans.
• Regulatory Impact Analysis: Ability to conduct formal assessments for design, manufacturing, labeling, software, process, supplier, and site changes and determine required regulatory actions.
• Technical Writing: Ability to write clear, accurate, and well-structured regulatory submissions, technical summaries, response letters, regulatory assessments, and internal decision documentation.
• Cross-Functional Collaboration: 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.
• Project Execution: 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.
• Problem Solving and Risk Escalation: Ability to identify regulatory obstacles, assess regulatory risks, recommend pragmatic solutions, and escalate issues requiring strategic decision-making.
• Standards and Guidance Interpretation: Experience interpreting FDA guidance documents, recognized consensus standards, ISO 14971, IEC 62304, IEC 60601, and other applicable standards.
• Communication and Influence: Strong verbal and written communication skills with the ability to explain complex regulatory topics clearly across multiple organizational levels.
• Organization and Attention to Detail: Ability to maintain accurate regulatory files, organize complex technical documentation, and ensure submissions are complete and inspection-ready.
• EU/International Awareness: Familiarity with EU MDR technical documentation, ISO standards, and OUS registration support is preferred but secondary to U.S. FDA regulatory expertise.
• Ethical Judgment and Integrity: Commitment to regulatory compliance, data integrity, and ethical decision-making in all regulatory activities

Physical Requirements / Work Conditions:

• Prolonged periods of sitting at a desk and working on a computer.
• Ability to travel domestically up to 5% of the time; may require walking through airports, carrying luggage, and navigating various transportation modes.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position

Elucent Medical Benefits, Culture and Work Environment

At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life. Fulltime Employees are provided:

• 401(k)
• 401(k) matching (4%)
• Dental insurance
• Health insurance
• Vision insurance
• Paid Holidays
• Paid Vacation Days
• Paid Sick Days
• Short Term Disability
• Long Term Disability
• Life Insurance
• Pet Insurance
• Employee Assistance Programs

Affirmative Action / EEO Statement

Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.