Provide technical leadership in the development and implementation of regulatory strategies to support the achievement of business objectives, while ensuring compliance with domestic, device, and consumer product regulations, with a strong focus on the Health Canada, EPA and Consumer Product Safety Commission Agency.
Primary customers include Kimberly-Clark North America, K-C International, and Corporate Innovation business units including their respective management team, mill/plant operations, and quality management teams, R&E, Legal, Quality Assurance, Global Clinical Affairs, Global Product Safety, Purchasing, Logistics, suppliers and contract manufacturers.
Expectations and Responsibilities:
Provide guidance to departments or development project teams regarding design, development, evaluation (e.g., bench testing, human use studies), or marketing of products to ensure regulatory requirements are met.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures and affected K-C business units.
Uses relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards and provide an interpretation of regulatory requirements to the appropriate business team members.
Provide leadership to ensure that regulatory submissions as appropriate are prepared and submitted accurately, completely and in a timely manner to meet business objectives, consulting with regulatory agencies as appropriate for clarification.
Anticipates and assists in the resolution of regulatory and/or quality issues or inquiries and recommends corrective action.
Demonstrates one K-C behavior in all business interactions to ensure that the RA team attracts, develops and retains the best people, and fosters an environment which motivates a diverse team to fully use its capabilities in achieving desired business results.
Incumbent reports to Associate Director - Global Regulatory Affairs. He/she provides direction, advice, and assistance to the organization’s facilities, business sectors and team members on regulatory compliance and knowledge management. Enables market access for Consumer Products and Medical Devices products throughout North America by developing knowledge of the regulations (EPA, Health Canada and Consumer Product Safety Commission Agency) and developing and implementing strategies and processes for getting products to market in a timely and cost-effective manner.
A broad technical background is required; preferably a graduate level degree, or as a minimum, a bachelor’s degree in a major scientific discipline, preferably chemistry or microbiology and/or 8 to10 years of relevant technical experience, including direct experience in compliance with EPA regulatory approval process, and other consumer product regulations such as the US and Canadian Consumer Product Safety Commission regulations.
The incumbent must possess an understanding of process, manufacturing, engineering, market research, marketing and legal matters obtained through experience and/or advanced education.
Experience supporting several product platforms, with a company that has sales volumes in the $B range.
Additional Salary Information: Negotiable based on experience.
Kimberly-Clark is a leading global health & hygiene company and home to some of the world's most trusted and recognized brands: KLEENEX, SCOTT, HUGGIES, PULL-UPS, KOTEX, DEPEND, AND WYPALL.As a world-class employer, Kimberly-Clark offers a stable work environment, career development, competitive pay and benefits. Opportunity for advancement with demonstrated proficiency through our employee caree...r development process. If interested and qualified, please apply online only at www.kc-careers.com. Select North America, create an online profile and resume, and apply to any qualified Requisition.