QRC Specialist - Innovation (Project Management)

QRC Specialist - Innovation

Job Description

You're not the person who will settle for just any role. Neither are we. Because we're out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you'll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In this role, you'll help us deliver better care for billions of people around the world. It starts with YOU. 

As the QRC Specialist – Innovation, you will assist with the implementation of global regulatory strategies to ensure global management of enterprise or innovation level regulatory compliance.  You will strategize and communicate with the business and functional partners on anticipated and existing regulation and legislation in support of product development and regulatory compliance during life cycle management of the K-C product portfolio.

In this role, you will:

• Execute all regulatory activities in accordance with corporate policies and practices, protection of proprietary information, and compliance with applicable laws and regulations.

• Act as the primary interface to the global regulatory affairs teams.

• Develop and execute global, innovative regulatory strategies that ensure compliance with global regulations, with a strong focus on North America US FDA and USDA regulations.

• Advise on regulatory intelligence, governance, best practices, and process improvements. Support product development activities in accordance with enterprise or business launch plans.

• Assist in preparing regulatory submissions for the introduction of novel products in accordance with global regulatory requirements.

• Establish and maintain positive customer rapport while driving solutions to meet business needs. Develop and maintain a strong spirit of partnership.

• Support the interpretation of existing regulations and those under development relative to the diverse K-C product range. Subsequently, identify and advise on communicating the impact of these regulations to the relevant K-C stakeholders.

• Assist with advisement on the applicability of new or proposed legislation changes on marketed products and the innovation pipeline, communicating these developments to senior Innovation, functional, or business leaders.

• Assist with conducting due diligence for partnerships, mergers, acquisitions, licensees, etc., as requested.

• Serve as an agency and topic area expert level SME internally with responsibility for external opportunities with agencies, Industry Associations, and/or working groups.

• Support challenging communication situations internally or with external agencies/regulators to ensure business outcomes.

• Maintain and demonstrate a working level knowledge and skill in products, quality systems, processes, and regulations.

• Up to 10% travel to other Kimberly-Clark locations

About Us

Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. Kimberly-Clark Professional®. You already know our legendary brands—and so does the rest of the world. In fact, millions of people use Kimberly-Clark products every day. We know these amazing Kimberly-Clark products wouldn't exist without talented professionals, like you.

At Kimberly-Clark, you'll be part of the best team committed to driving innovation, growth and impact. We're founded on more than 150 years of market leadership, and we're always looking for new and better ways to perform – so there's your open door of opportunity. It's all here for you at Kimberly-Clark.

Led by Purpose. Driven by You.

About You

You perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring.  You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development.
You love what you do, especially when the work you do makes a difference. At Kimberly-Clark, we're constantly exploring new ideas on how, when, and where we can best achieve results. When you join our team, you'll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business.

In one of our professional roles, you'll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center. To succeed in this role, you will need the following qualifications:

• A Bachelor's degree in Sciences, Business, Engineering, Operations, or equivalent degree and 5 years or more of prior relevant experience OR a Master's degree in relevant field and 3 or more years of prior relevant experience.

• Experience in a regulatory product clearance role in a medical device, pharmaceutical, consumer goods, cosmetic, chemical, or similar environment to achieve market access for finished products for sale in multiple regions or geographies.

• Subject matter expertise in global regulatory requirements for medical devices and consumer products. Interaction and experience working with global regulatory bodies as well as knowledge of major regulatory frameworks (e.g., US FDA Medical Device, USDA, Consumer; Cosmetics; EPA Pesticides/Biocides, textile, and international regulatory bodies processes for similar product categories).

• Experience with cross-functional early research and new product development teams and coaching through programs for regulatory success throughout the product lifecycle.

• Expert level technical and subject matter expertise in product regulatory requirements and executing complex regulatory strategies. Provide regulatory guidance to achieve business outcomes.

• Demonstrated leadership experience within a complex, matrix, or multi-business organization.

• Ability to communicate at all levels of the organization and manage through complex compliance challenges to successful resolution.

• Advanced ability to work across functional and technical boundaries without hesitation.

• Working level knowledge of functional and technical expertise.

• Works independently with strategic direction for activities in areas of expertise and responsibility.

• Experience with industry trade associations, regulators, and strategic customers.

Total Benefits

Here are just a few of the benefits you'd enjoy working in this role for Kimberly-Clark. For a complete overview, see www.mykcbenefits.com.
 

Great support for good health with medical, dental, and vision coverage options with no waiting periods or pre-existing condition restrictions. Access to an on-site fitness center, occupational health nurse, and allowances for high-quality safety equipment.

Flexible Savings and spending accounts to maximize health care options and stretch dollars when caring for yourself or dependents.

Diverse income protection insurance options to protect yourself and your family in case of illness, injury, or other unexpected events.

Additional programs and support to continue your education, adopt a child, relocate, or even find temporary childcare.

To Be Considered
Click the Apply button and complete the online application process. A member of our recruiting team will review your application and follow up if you seem like a great fit for this role.

In the meantime, please check out the careers website.

And finally, the fine print….

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.

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.

Employment is subject to verification of pre-screening tests, which may include drug screening, background check, and DMV check.

Additional information about the compensation and benefits for this role are available upon request. You may contact 866-444-4516 – when prompted for employee ID, say “OTHER CALLER” - or kcchrprod@service-now.com for assistance. You must include the six-digit Job # with your request.

Veterans and members of the Reserve and Guard are highly encouraged to apply.

Kimberly-Clark will support in-country relocation for the chosen candidate for the role.  The benefits provided will be per the terms of Kimberly-Clark's applicable mobility policies. The benefits/policy provided will be decided at Kimberly-Clark's sole discretion.

Primary Location

Dallas World Headquarters

Additional Locations

USA-GA-Atlanta-Roswell, USA-WI-Neenah

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time