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Job Description
Regulatory Affairs Program Manager at Lumicity Regulatory Affairs Program Manager at Lumicity in Mountain View, California Posted in 1 day ago.
Type:
full-time
Job Description:
Regulatory Program Manager About the
Company:
A growing ultrasound medical device company is seeking a Regulatory Program Manager to support the development and regulatory advancement of next-generation ultrasound technology. The company is building innovative hardware and software-enabled medical systems designed for use in clinical environments. This is an in-person role based in the San Francisco Bay Area.
Position Overview:
The Regulatory Program Manager will be responsible for driving cross-functional medical device programs through key development, documentation, and regulatory submission milestones. This person will work closely with Regulatory Affairs, Quality, Engineering, Clinical, Operations, and Product teams to ensure project timelines, deliverables, design control documentation, testing plans, and submission materials remain organized, complete, and inspection-ready. The initial focus will be supporting FDA 510(k) submission activities for new and updated products. Over time, the role may also support additional regulatory pathways, including IDE, CE Mark, EU MDR, and other international submissions. This is not the final regulatory approver role. Instead, this person will own the program structure, timelines, cross-functional coordination, risk tracking, and documentation readiness needed for Regulatory Affairs to prepare, submit, and support regulatory filings.
Key Responsibilities:
Lead cross-functional medical device programs from early development through regulatory submission and early commercialization. Build and manage integrated project plans covering scope, timelines, dependencies, milestones, owners, critical path items, and resource needs. Partner with Regulatory Affairs to translate regulatory strategy into clear deliverables, timelines, and documentation requirements. Coordinate submission readiness for FDA 510(k), IDE, CE Mark, EU MDR, and other applicable regulatory pathways. Drive alignment across engineering, clinical, quality, manufacturing, product, and regulatory teams to ensure program goals remain on track. Support preparation of technical documentation, testing deliverables, labeling inputs, risk documentation, and design history file materials. Coordinate design control activities, including user needs, design inputs, design outputs, design reviews, verification and validation planning, traceability, risk management, and DHF completion. Ensure teams maintain documentation in accordance with
FDA QSR, 21 CFR 820, ISO
13485, and applicable design control expectations. Track program risks, open issues, decision points, escalations, and mitigation plans. Facilitate core team meetings, executive updates, status reporting, and cross-functional program reviews. Support responses to regulatory questions by coordinating technical input from subject matter experts. Manage external project dependencies, including test labs, consultants, vendors, and development partners. Support evidence-generation activities such as data collection, usability testing, validation documentation, and other materials needed for regulatory submissions. Help implement and improve project management tools, dashboards, risk registers, and operating rhythms within a regulated medical device environment.
Qualifications:
7 to 10+ years of experience in medical device product development, regulatory program management, or related technical project leadership. 3 to 5+ years of experience managing cross-functional programs in a regulated medical device or healthcare technology environment. Experience supporting Class I or Class II medical devices through regulatory milestones such as 510(k), IDE, CE Mark, EU MDR, or similar international submissions. Strong working knowledge of
FDA QSR, 21 CFR 820, ISO
13485, design controls, and risk management principles. Experience coordinating design control documentation, DHF readiness, verification and validation planning, and regulatory submission inputs. Ability to manage complex project plans, identify critical paths, track dependencies, and drive execution across multiple teams. Experience working with engineers, clinicians, scientists, quality leaders, regulatory teams, operations, and executive stakeholders. Familiarity with tools such as Jira, Smartsheet, MS Project, eQMS platforms, PLM systems, or similar project and documentation tools. Strong communication, organization, and escalation management skills. Comfortable operating in a fast-paced, hands-on medical device environment.
