Job Description

Position Purpose:

• Provide functional and technical leadership in the development and implementation of regulatory strategic direction to support the achievement of business objectives for client K-C Professional business units, while ensuring compliance with domestic and international Class I and II medical device regulations.
• Provide regulatory product strategies, influence, and make strategic recommendations and input to other Quality, Regulatory and Compliance (QRC) functions for a cohesive QRC response to the business units that will ensure corporate compliance with the regulations.
• Provide regulatory training and influence strategic decision making to regulatory colleagues, the research and development teams and cross functional partners in support of new technology development that is cognizant of product testing and other requirements for regulatory approval in global markets in order to meet launch timelines.

Customers:

Primary customer is K-C Professional North America (NA) including respective management teams, global business management teams; R&E, Legal, and QRC functions including Business Quality, Global Quality Assurance, Global Product Safety and Clinical Affairs, Global Medical Affairs, Purchasing, Logistics, suppliers and contract manufacturers.

Expectations:

• Serve as primary regulatory contact with NA Health Authorities when required.
• Provides regulatory affairs leadership and support in the development, improvement programs and/or projects involving department or cross-functional teams.
• Communicate appropriately with all customers, conducting all communications and transactions with the utmost integrity and honesty so as to build an unimpeachable business reputation.
• Serve as liaison with regional regulatory affairs counterparts for global projects.
• Provides technical leadership and expertise to support teams in manufacturing and marketing full ranges of products in the US and Canada.
• Manage teams and self in accordance with the expected behaviors of the Leadership Qualities.
• Develop and implement domestic, international, and where appropriate, product-specific regulatory strategies in support of business objectives.
• Monitor the development of regulatory initiatives and communicate potential business impact to business and QRC senior management.
• Provide interpretation on and training of domestic and international regulatory requirements to the appropriate business and QRC partners and team members.
• Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective actions.

Scope:

• The incumbent is responsible for establishing and maintaining regulatory strategies designed to effectively and efficiently support business objectives.
• This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized quality and regulatory expertise based on an in-depth knowledge of technical and business practices.
• The incumbent integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client businesses.

Principal Accountabilities:

• Provide strategic and functional leadership, expertise and counsel that result in the development, manufacture and placing on the market products that provide quick and cost-effective routes to market, and which comply with the applicable regulatory requirements.
• Represent Kimberly-Clark’s interests at Trade Associations, in order to gain knowledge and influence regulations and standards by collaborating with other similar companies.
• Actively participate in the Innovation process and project teams by providing targeted feedback on proposed product formulations and/or product designs to ensure potential regulatory hurdles are identified at the earliest stages of a project and appropriate business decisions can be made.
• Establish and maintain processes and provide leadership to ensure that regulatory submissions and responses, such as those for FDA and Health Canada and various international regulatory submissions are prepared and submitted accurately and completely in a timely manner to meet business objectives
• Establish and maintain an information network for purposes of monitoring domestic and international regulatory developments, followed by appropriate preventive communication and training within the K-C business units.
• Lean in to challenging communication situations both internally and externally to ensure business outcomes.
• Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances.

Qualifications/Education/Experience Required:

• A broad technical background is required; preferably a graduate level degree, PhD, MBA or Masters, or as a minimum, a bachelor’s degree in a major scientific discipline and 10+ years of relevant technical experience, including FDA and Health Canada regulations for medical devices, for example, the 510(k) process.
• Must possess an understanding of the product development process including product design/formulation, manufacturing, engineering, marketing and legal matters obtained through experience and/or advanced education and the implications on a global launch of a given product.
• The incumbent must also possess extensive experience with medical device labeling, advertising promotion and claims review experience to ensure compliance with US FDA and Health Canada regulatory requirements.

Kimberly-Clark makes the essentials for a better life with well-known brands that matter every day – at home, school, work and on the go. Throughout our 148 years, we have challenged conventional wisdom to innovate products that better meet the needs of consumers. We have created new categories with top brands like Kleenex®, and redefined categories with Huggies® and U by Kotex®. While growing our $18+ billion global business, we help build careers through collaborative teams that push boundaries and endless opportunities to work with some of the world’s most recognized brands. Our 43,000 employees are changing the world for the better, too, generously giving back to communities and causes around the globe.

For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law.

With an inclusive culture, our employees – and the original thinking they bring to Kimberly-Clark – make us stronger. EOE disability/vet.

K-C requires that an employee have authorization to work in the country in which the role is based. In the event an applicant does not have current work authorization, K-C will determine, in its sole discretion, whether to sponsor an individual for work authorization. However, based on immigration requirements, not all roles are suitable for sponsorship.

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