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 behaviors 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.
Sales Volume: $19 Billion
Supporting several product platforms
Provide Regulatory leadership for Family Care and Baby and Child Care Consumer Products and EPA products. Also KCP EPA products.
Participate on project teams developing/launching new products by defining regulatory requirements and develop regulatory strategies and/or complete assessments to ensure compliance and successful achievement of business objectives.
Prepare regulatory submissions as appropriate for approval of new products.
Establishment and licensing requirements to ensure compliance with governmental agency expectations.
Establish and maintain an information network for purposes of monitoring and maintaining a current knowledge base of existing emerging regulations, standards, and guidance documents, followed by appropriate preventive communication and training within the K-C business units.
Establish and maintain a process to participate in the review of process/product changes, labeling, claims, complaints, etc., to ensure compliance to internal QMS, EPA and international requirements and provide notification to regulatory authorities as required.
Serve as a liaison for RA internally with Product Safety, business quality assurance units, legal and other regulatory resources as well as externally with the EPA and/or health ministries, CPSC and consulting organizations.
Write or update standard operating procedures, work instructions, or policies as appropriate
Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or No. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.
Kimberly-Clark is an 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. This position is subject to drug and alcohol testing, including pre-employment testing.
The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
This position may require a post-offer/pre-hire Physical Abilities Test (PAT) to confirm that individuals are able to perform the essential functions of the job.
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. This position is subject to drug and alcohol testing, including pre-employment testing.
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.
Kimberly-Clark and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, 1.3 billion people - nearly a quarter of the world's population - trust K-C brands and the solutions they provide to enhance their health, hygiene, and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex, and Depend, Kimberly-Clark holds No.1 or N...o. 2 share positions in more than 80 countries. With more than 140 years of history of innovation, we believe in recruiting the best people and empowering them do their best work. If fresh thinking and a passion to win inspire you, come Unleash Your Power at Kimberly-Clark.