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Principal Regulatory Affairs Specialist - Product Steward

Employer
medtronic
Location
Minneapolis
Salary
Competitive

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PRINCIPAL REGULATORY AFFAIRS SPECIALIST (Product Steward)Careers that Change LivesThe Principal Regulatory Affairs Specialist (Product Steward) provides leadership and direction for the development and implementation of programs and systems focused on environmental product and packaging sustainability, compliance and disposition to comply with international, federal, state and local Product Stewardship regulations, customer and investor requirements, company policies, strategies, initiatives and goals and well as other responsibilities as described below.A Day in the LifeWe offer you a position where you would:Lead and manage the the development, implementation and updates of environmental product and packaging sustainability, compliance and disposition programs and systems to comply with international, federal, state and local Product Stewardship regulations, customer and investor requirements, company policies, strategies, initiatives and goals. Major areas of emphasis include: Develop strategies and provide leadership to effectively integrate sustainable Product Stewardship programs, systems and processes into business systems to drive compliance with environmental product and packaging regulations. Develop and lead implementation of systems to support data collection and management for identifying and reporting product and packaging materials and attributes for regulatory, customer and/or investor reporting. Participate and communicate product and packaging sustainability practices through internal and external groups. Identify and promote world class Product Stewardship programs and provide leadership to leverage competitive advantage and reduce risks to the company and employees. Partner with and educate business functions to assure that employee safety, environmentally sustainable practices and compliance with Product Stewardship regulations (i.e. REACH, RoHS, CA Prop 65, EU MDR, etc) are supported.Must Haves Bachelor's Degree Minimum 7 years of medical device regulatory experience or an advanced degree and a minimum 5 years' of medical device regulatory experience in one of the following area(s) Regulatory Product Stewardship Materials Science Materials Engineering R Toxicology Chemistry Biology Engineering Environmental ScienceNice to Haves Master of Science Degree in Chemistry, Materials Engineering, Environmental Engineering, or Toxicology, etc. Deployment of environmental product and packaging sustainability, compliance and disposition programs in a multinational organization. Understanding of testing hazardous substances to Product Stewardship requirements Assess supplier certifications for compliance requirements Excellent knowledge and experience with Product Stewardship regulations. Experience in cultivating a broad network of relationships with key internal and/or external stakeholders throughout the organization. Strong leadership and influence management skills Ability to make decisions and work independently Proven technical, problem solving, and project management skills Excellent communication and training skills required. Self-motivation with ability to multi-task, prioritize and organize work to meet deadlines and multiple requests Must have excellent computer skills and familiarity with database management and reporting. Willingness to work flexible hours and travel to diverse work locations. Ability to discern and appropriately communicate sensitive issues Travel up to 10%.About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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