Regulatory Affairs Specialist Jobs

: Job Title: Contingent Support Regulatory Affairs

Remote Position, however, Wisconsin/Neenah local to work hybrid remote/on-site is extremely desired .

Some project management experience is helpful.

:

• Provide regulatory support in the development and implementation of regulatory strategies to achieve business objectives for Kimberly-Clark North America Business, while ensuring compliance with the US FDA and Health Canada Class I medical devices, Consumer Products and Cosmetics regulations.

• Provide regulatory assessments to the research and engineering (R&E) teams in support of design controls and change management in cognizant of product testing and other requirements for regulatory compliance.

• Provide regulatory support on Labeling and Ad Promo (Artwork/copy doc.) reviews and approvals.

• Provide regulatory support with procedures/SOP development and continuous improvements.

• Make regulatory impact assessment on Advance Warning Assessment Tool.

Primary (internal) customers include all cross functional teams for the KC North America Adult Feminine Care, Family Care, and Baby & Child Care business units including R&E, Legal, Quality, Regulatory, Product Safety, and Marketing.

Important Elements to be Successful on the Job:

• Understanding the various Kimberly-Clark domestic and international business needs.

• Understanding and interpreting domestic and international regulations relative to new technology, and product development.

• Having the ability to understand the technical aspects of the vast array of regulated products manufactured and/or marketed by the Kimberly-Clark business units.

• Have the insight to problem-solve proactively on regulatory and associated quality issues.

• Understanding various regulatory options for rapid commercialization of new technologies while keeping the businesses informed of costs, timing and competitive access.

• Comply with K-C policies, internal controls and global regulations.

Qualifications/Education/Experience Required:

• Regulatory experiences on Class I Medical Device, Consumer Products and Cosmetic Products.

• A bachelor’s degree in a life science discipline and 5 to 7 years of relevant regulatory experience, including FDA and Health Canada regulations.

• Understanding of US FDA Design Controls Process including product design/formulation, manufacturing, engineering, marketing and legal matters.

PRINCIPAL ACCOUNTABILITIES:

1. Participate and work independently on project teams developing/launching products by defining regulatory requirements and necessary regulatory deliverables to ensure compliance and successful achievement of business objectives.

2. Actively participate in the Innovation management process by providing targeted feedback on proposed product designs to ensure potential regulatory hurdles are identified at the earliest stages of a project and appropriate business decisions can be made.

3. Assess regulatory pathway for new product platforms and product modifications; Develop regulatory strategies, regulatory summaries, assessments and tactical plans to ensure compliance with FDA and Health Canada regulatory requirements.

4. Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for U.S and Canada. Followed by appropriate preventive communication and training within the K-C business units.

5. Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances

6. Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.

7. 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.

8. Collaborate with Research and Engineer, Marketing, and legal teams in the development of compliant medical device labeling and product claims.

9. Provide advice and counsel to staff and global manufacturing facilities regarding compliance with FDA, Health Canada Quality System requirements, as well as international and national standards, when necessary.

• 10. Support the regulatory intelligence monitoring program by assessing changes in regulation and determining impact to K-C medical device products.