Senior Manager, Instructional Design and Labeling Operations

About the role

The Senior Manager, Instructional Design and Labeling Operations will lead the Instructional Design team within Customer Experience and Design, supporting the development, lifecycle management, review, and operational execution of Instructions for Use (IFUs), Native Artwork Files (NAFs), and related instructional artwork deliverables for combination products and other regulated medical products.

Responsibilities

• Lead, coach, and develop a team of Instructional Design Engineers

• Build a high-performing team culture grounded in accountability, collaboration, learning, quality, operational discipline, and customer focus

• Manage team priorities, workload, capacity, onboarding, performance, development, and resource allocation

• Provide effective oversight of external workers and/or contractors, including onboarding, work assignment, deliverable expectations, execution quality, and integration into team workflows

• Navigate ambiguity, competing priorities, cross-functional dependencies, and escalation needs

• Translate portfolio needs, Human Factors milestones, labeling deliverables, study timelines, submission needs, and business priorities into executable team plans

• Establish mechanisms to monitor workload, workflow health, quality trends, cycle times, risks, rework drivers, and delivery commitments

• Strengthen the operating model for Instructional Design and Labeling Operations, including role clarity, decision rights, intake, prioritization, escalation, metrics, and cross-functional handoffs

• Ensure the teams work supports broader Customer Experience objectives, including improved patient learning materials, usability, complaint reduction, and customer experience outcomes

• Lead process improvement efforts across the IFU / NAF lifecycle, including NAF strategy, creation, revision, review cycles, Human Factors study support, source text alignment, submission support, vendor coordination, and launch readiness activities

• Develop, maintain, and improve supporting tools such as templates, checklists, standards, process maps, training materials, metrics, and review expectations

• Identify and resolve process gaps, handoff inefficiencies, documentation risks, role clarity issues, recurring workflow pain points, and compliance vulnerabilities

• Champion scalable and compliant ways of working that improve predictability, audit readiness, quality, speed of execution, and team sustainability

• Build strong partnerships with Human Factors, Regulatory Labeling, Packaging Engineering, Artwork Center, Systems Engineering, Quality, Final Product Teams, vendors, and other partners

• Represent Instructional Design and Labeling Operations in portfolio, program, governance, and process discussions where team commitments, risks, vendor performance, or functional strategy are impacted

• Communicate priorities, risks, decisions, and tradeoffs clearly to senior leaders and cross-functional stakeholders

• Influence across matrix teams to drive alignment, remove barriers, and maintain momentum

• Manage vendor and contractor relationships to support execution, capacity, quality, specialized capability, print readiness, study support, and process reliability

• Ensure vendors and external partners understand applicable expectations, timelines, deliverable standards, documentation needs, and escalation pathways

• Ensure Instructional Design and Labeling Operations activities are performed and documented in accordance with applicable procedures, standards, and regulatory expectations

• Promote strong documentation practices, including traceability of inputs, decisions, reviews, revisions, approvals, study support activities, and submission-related deliverables

• Support audit readiness, inspection readiness, and response to Health Authority questions or feedback related to Instructional Design and labeling operations deliverables

• Drive a culture of quality ownership, right-first-time execution, and continuous learning from errors, rework, study outcomes, stakeholder feedback, and process metrics

Qualifications

• Doctorate degree and 2 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience

• Masters degree and 6 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience

• Bachelors degree and 8 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience

• Associates degree and 10 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience

• High school diploma / GED and 12 years of regulated labeling, medical device, combination product, instructional design, Human Factors, design operations, process improvement, product development, quality, or related experience

Preferred Qualifications

• Demonstrated people leadership experience, including coaching, performance management, career development, workload management, and building high-performing teams

• Experience leading FTEs, external workers, contractors, vendors, or matrixed contributors in a regulated or quality-sensitive environment

• Experience in regulated medical product labeling, artwork, packaging, Human Factors, medical device, pharmaceutical, biotechnology, combination product, quality, or design operations

• Combination product experience preferred; broader regulated medical space labeling or artwork experience may be suitable

• Experience improving processes, implementing SOPs, developing templates/checklists, defining role clarity, and scaling functional operations

• Experience owning or governing controlled procedures, including implementation, adherence, training, inspection readiness, and continuous improvement

• Knowledge of IFUs, instructional materials, labeling/artwork development, Human Factors study materials, Health Authority submission support, or regulated document workflows

• Experience with document management systems, review workflows, source text/artwork alignment, traceability, and audit-ready documentation

• Vendor management experience, including defining expectations, managing deliverables, monitoring performance, and resolving quality or timeline issues

• Strong cross-functional leadership and influencing skills with the ability to align stakeholders across technical, regulatory, quality, operational, and design perspectives

• Ability to manage multiple priorities, identify risks, escalate appropriately, and drive decisions in a matrixed environment

• Strong written, verbal, facilitation, and executive communication skills

• Demonstrated ability to translate customer, patient, user, and business needs into practical operational improvements

• Lean, Six Sigma, process excellence, change management, or operational excellence experience preferred