Manager Labeling - LABORIE Medical Technologies : Job Details

We believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it's what fuels our motivation and contributes to our success. If you're ready to make a positive impact in the lives of patients across the globe, we'd like to meet you.We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good.We're not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values ofAspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.Who We're Looking For:TheManager of Labelingmanages the Technical Documentation Group (TDG) team and is a Subject Matter Expert (SME) responsible for managing device labeling (including, but not limited to labels, IFUs, and UDI) as necessary to market our medical devices worldwide.About the Role:

• Manage and support Technical Documentation Group (TDG) team members to ensure priority of deliverables are achieved in a timely manner; Develops and mentors the team with the goal of ensuring high quality and performance.
• Applies understanding and demonstrated leadership of label development, IFU development, change management systems, and global labeling regulations, requirements, procedures, and concepts.
• Guides the team in the review of product specifications and other regulatory documentation to ensure label compliance. Reviews promotional material for compliance with application regulations and product claims.
• Review labeling to ensure content is accurate, complete and current, and investigate any label discrepancies, missing documentation and inaccuracies as part of the change control for global products, by ensuring labeling compliance with the applicable medical device and food regulations.
• Liaison with Regulatory, Marketing, Operations and Sales of and manage changing properties to support label change projects including launches, promotions and packaging updates; Apply quality system knowledge and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits.

Minimum Qualifications:

• Bachelor's degree in related sciences or a technical field with previous Labeling experience in the medical device industry (minimum 5 years).
• Proficient in Acrobat and advanced personal computer skills including MS Office or equivalent.
• Experience with translation projects and working within an international organization.
• Strong people and project management skills, specifically the ability to prioritize/manage multiple projects simultaneously, sometimes with short or changing deadlines.

Why Laborie:Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

Laborieprovidesequal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexualorientation,or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities. #J-18808-Ljbffr