Labeling Program Manager
The Labeling Program Manager is responsible for managing Inogen's labeling projects and processes for new product development, design changes, and sustaining or maintenance projects. This position coordinates cross-functional resources and schedules to deliver labeling plans and deliverables on-time, and in alignment with company-wide priorities. The Labeling Program Manager will work closely with the engineering, regulatory affairs, quality assurance, operations, marketing/product management, and supply chain personnel to facilitate and execute project activities.
The Labeling Program Manager will ensure that regulatory standards are adhered to throughout design and development activities and are thoroughly planned, documented, and executed to comply with best practices in the medical device industry. The Labeling Program Manager will be the process owner for all labeling design and development activities.
Responsibilities (Specific tasks, duties, essential functions of the job)
- Manage projects of varying size and complexity from concept to production per internal procedures and regulatory standards for labeling development and projects.
- Manage labeling design change projects for sustaining activities, new market releases, product updates, and standard updates, including software and hardware solutions identified to achieve desired results.
- Collaborate cross functionally to manage life cycle planning to ensure that labeling is compliant with regulatory standards as they are updated, published, and adopted.
- Manage timelines, milestones, budget, and labeling costs, and report deliverable status to cross-functional team and management, as applicable.
- Effectively communicate and collaborate with Engineering, Product Management, Regulatory, Quality, Supply Chain, IT, Medical Affairs, and Operations, and any other pertinent internal or external stakeholders to define labeling requirements, make decisions, and accomplish objectives.
- Conduct meetings and track project status to set goals, monitor timelines, align expectations, facilitate cross-functional communication, and ensure task completion.
- Coordinate and execute product development activities for all device labeling (primary product, accessories, components, etc.), packaging labeling, IFUs/manuals, customer facing literature, and other documents.
- Coordinate and support verification and validation activities for internal and external labeling testing, release of documentation, and any labeling hardware/software validations.
- Key stakeholder in defining new and improved business processes to support labeling for compliance, implementation, and manufacturing.
- Promote teamwork and motivate others to solve challenges in a productive and positive manner.
- Maintain regular and punctual attendance.
- Comply with all company policies and procedures.
- Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
- Must have strong work ethic.
- Analytical & problem-solving skills & ability to multitask.
- Solutions-oriented problem solver.
- Excellent planning, communication and organizational skills.
- Strong background in Project Management and Labeling best practices, preferably according to PMP processes.
- Excellent oral and written communication skills as well as excellent presentation skills with ability to conduct presentations comfortably to large groups.
- Demonstrated capability for problem solving, decision making, and conflict resolution.
- Proven leadership ability with an emphasis on accountability and conflict management.
- Strong relationship building and interpersonal skills.
- Strong understanding of FDA/ISO Design Control requirements required.
- Attention to detail and follow through required.
- Passion for product quality and excellence required.
- Strong technical writing and organizational skills required.
- Ability to multitask in a fast-paced team environment required.
Qualifications (Experience and Education)
- Bachelor’s degree required. Technical field, preferred.
- 5 years of experience in project management, required; in medical device, regulatory, preferred.
- 5 years of experience in medical device industry, with 10 years total industry experience, required.
- Project management certification from PMI or equivalent, preferred.
- Fluent in MS Project, Excel and other MS Office applications, required.
- Advanced knowledge/proficiency ISO 13485, MDD or MDR, required.
- Advanced knowledge in FDA GMP and ISO regulated quality systems, required.
- Fluent with Oracle, SAP, or equivalent, required.
- Fluent with CAD design, SOLIDWORKS experience, preferred.
- Knowledge of global regulatory landscape, preferred.
- A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.
- Ability to travel up to 25% annually, required. Ability to travel monthly to Goleta, CA, preferred.
- Job Function Individual Contributor
- Pay Type Salary
- Employment Indicator Insider
- Required Education Bachelor’s Degree
- Goleta, CA, USA