Job description
About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries
About the Role: We are looking for a Medical Products Division (MPD) Regulated Product Labeling Director to join our team. In this role, you will be responsible for the development of product labeling that is compliant with requirements of US FDA, European Notified Body and other global regulatory bodies as appropriate. You will work in conjunction with manufacturing, quality assurance, regulatory, IT, operations, technical and product development teams.
This position offers multiple work arrangements: on-site at our Phoenix 2 facility in Phoenix, Arizona, hybrid or fully remote work allowed in Phoenix or Flagstaff, depending upon the responsibilities of the role and business needs.*
- Provide leadership for the MPD Product Labeling Team through team vision, mission and execution strategies and ensuring a robust feedback loop to team members on their contribution, performance, development and meeting of shared expectations
- Lead a specialized team of project managers and graphic designers to deliver compliant product labeling components to manufacturing in support of new product development and commercial product sustainment in all global markets
- Serve as a member of the MPD Finished Good Supply Chain (FGSC) leadership team to collaborate with all FGSC functions in developing, establishing and meeting priorities, goals and strategies to meet divisional business needs around the globe
- Develop team strategies and project roadmaps to meet challenges and evolving requirements within a dynamic global regulated environment and complex supply chain
- Work effectively with diverse cross-functional teams to define, scope and manage changes to print and electronic product labeling components
- Understand the needs and requirements of medical professionals and driving enhancements into the product labeling strategies and project roadmaps
- Define, establish and maintain current and future system designs and integrations to improve the efficiency and accuracy of product labeling development, implementation and delivery
- Provide direction, training, mentoring and coaching to the MPD Product Labeling Team, as well as other functional team associates, to develop a cohesive understanding of product labeling processes and procedures
- Establish clear expectations of equitable and inclusive behaviors from Associates and acting immediately to appropriately address negatively impactful or unfair behavior
Required Qualifications:
- Bachelor's degree and a minimum of 2 years of high-level medical device labeling experience OR a minimum of 5 years of high-level medical device labeling experience
- Experience quickly establishing credibility within a team and providing leadership to direct team members and functional partners
- Demonstrated experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices
- Demonstrated understanding of labeling requirements, quality system structure, change control, labeling system design and integrations between business systems
- Proficiency in standard business software, specifically Microsoft Word, PowerPoint, Excel and Project
- Excellent oral and written communication and interpersonal skills and the ability to convey that communication to functional partners in a clear and concise manner with defined milestones and timelines
- Effectively interacting with and influencing manufacturing, quality assurance, regulatory, IT, operations, technical and product development team associates, as well as external suppliers
- A work style of hands-on involvement in all phases of projects and their interactions, including roadblock and conflict resolution
- Proven ability to lead, prioritize, plan, and drive a multitude of complex interdependent projects/initiatives to completion concurrently and with attention to detail
- Ability to travel up to 10% #LI-Remote #LI-DIR
Desired Qualifications:
- Proven track record of leading major medical product labeling initiatives and successful project completion
- Experience working within the global medical device regulated industry and the ability to translate requirements to product labeling execution
- In-depth knowledge of product lifecycle management (PLM) systems, labeling technologies, materials, specifications and systems, manufacturing processes and Quality System requirements
Desired Qualifications:
- Proven track record of leading major medical product labeling initiatives and successful project completion
- Experience working within the global medical device regulated industry and the ability to translate requirements to product labeling execution
- In-depth knowledge of product lifecycle management (PLM) systems, labeling technologies, materials, specifications and systems, manufacturing processes and Quality System requirements
- Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. For fully remote roles, the following locations are not eligible for new fully remote work arrangements: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact
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