Regulatory Program Manager

Job Description

Job Description

PURPOSE

The Regulatory Program Manager is a medical device project management role responsible for planning, coordinating, and driving cross-functional programs that initially support FDA 510(k) submissions for new and modified products, with future responsibility for helping define and prepare additional regulatory pathways such as CE Mark and other international approvals. This role owns program structure, timeline management, risk tracking, cross-functional alignment, and documentation readiness across product development activities, while partnering closely with Regulatory Affairs, Quality, Clinical, R&D, and Operations. The role is not the final regulatory signatory; instead, it ensures teams generate the inputs, design control outputs, and submission-ready documentation required for Regulatory Affairs to compile, submit, and defend filings.

SPECIFIC DUTIES AND RESPONSIBILITIES 

• Lead cross-functional medical device programs from concept through regulatory submission and early commercialization, including planning for FDA 510(k), IDE, and CE Mark / EU MDR milestones.
• Build and maintain integrated project plans covering scope, schedule, dependencies, critical path, resource needs, and decision points across engineering, clinical, manufacturing, quality, and regulatory teams.
• Drive program governance through recurring core-team meetings, issue resolution, escalation management, and executive status reporting.
• Partner with Regulatory Affairs to map submission strategy into concrete deliverables, owners, and timelines for technical documentation, testing, labeling, and design history file readiness.
• Coordinate development and completion of design control deliverables, including user needs, design inputs and outputs, design reviews, verification and validation plans, risk management files, traceability, and DHF documentation.
• Ensure project teams maintain inspection-ready documentation in compliance with FDA design control expectations under 21 CFR 820.30 and ISO 13485 quality system requirements.
• Manage external dependencies such as test labs, consultants, partners, and other vendors that contribute to verification, validation, and submission timelines.
• Support evidence-generation activities, including data collection, usability / human-factors testing, and related documentation, as needed to support regulatory submissions, product validation, and responses to regulatory questions. 
• Support responses to regulatory questions and submission follow-up requests by coordinating technical input from internal subject matter experts.
• Implement and improve project management tools, dashboards, risk registers, and cross-functional processes appropriate for a regulated medical device environment.

SUPERVISORY RESPONSIBILITIES

• None

EDUCATION

• Bachelor’s degree in Engineering, Sciences, or closely related technical field (e.g., Biomedical Engineering).

EXPERIENCE

• 7–10+ years of medical device product development experience with at least 3–5 years in project/program management roles.

KNOWLEDGE AND TRAINING

• Demonstrated experience leading cross‐functional teams delivering Class I/II medical devices or other regulated healthcare technologies (including capital equipment, wearables, or software‐enabled systems) through key regulatory milestones such as 510(k), IDE, CE Mark, and/or comparable international submissions. 
• Hands-on experience operating within FDA QSR (21 CFR 820) and ISO 13485 quality systems, with strong understanding of design controls and risk management (ISO 14971).
• Proven ability to build and manage integrated project plans, identify critical paths, and manage multiple concurrent projects.
• Proficiency with project and requirements tools such as Jira, MS Project or Smartsheet, and eQMS/PLM systems.