OPPORTUNITY

Kohler Ventures is an independent company wholly owned by Kohler Co., global leader in the manufacture of kitchen and bath products, tile and home interiors, and an international host to award-winning hospitality and world-class golf destinations. Our mission is to build new digital businesses that empower consumers to lead healthier lives. We explore how familiar experiences can be enhanced and innovations developed through the integration of leading-edge technology, science, and design. Come join us as we build a best-in-class global multi-disciplinary team across artificial intelligence, machine learning, design, advanced software and hardware engineering, strategy, venture investments, sales, marketing, and partnerships.
We are seeking a Compliance and Regulatory Lead (Product Compliance Manager - internal title) to support the regulatory, quality and clinical strategy for Kohler Ventures. The position will be integral to bringing Kohler’s first regulated wellness product to market. The ideal candidate should have experience engaging with regulatory bodies, filing submissions, gaining marketing authorization in the medical device industry. The position is an individual contributor role reporting to Head of Legal - Kohler Ventures.

In this role at Kohler Ventures you will:

• Secure US and select international regulatory authorization for health/wellness products
• Oversee maintenance of regulatory licenses, registrations and listings
• Work with commercial team to ensure advertising and promotions comply with regulations
• Inject organization with clinical insights and serve as subject matter expert on all clinical, scientific medical and regulatory matters
• Stay abreast of updates to regulatory landscape via intelligence gathering and attendance of tradeshows/workshops
• Act as a liaison to medical advisory board and other key opinion leaders

SKILLS/REQUIREMENTS

• 7+ years of regulatory experience in health care, life science and/or medical device manufacturing space
• A Bachelor’s degree from a reputed educational institution; MD/JD/Ph.D. or other advanced degrees highly preferred
• Must have a successful record of taking a new product in development through its first regulatory approvals from the FDA (510(k) and De Novo) in the US; international experience, especially in China, preferred
• Demonstrated experience creating research strategies and performing clinical trials working with CROs
• Commercial experience supporting bringing new product to market
• Extensive experience setting up and working with quality management systems (QMS); with deep knowledge of associated standards and compliance requirements
• Regulatory expertise in Software as a Medical Device (SaMD)
• Strong experience providing regulatory support to product and engineering teams across all stages of the product development lifecycle.
• Significant experience collaborating with Product Engineering to help them meet regulations while incubating at the speed of a startup.
• Capable of working in cross-functional environment and developing relationships with medical advisory board members and regulatory bodies
• Desire to roll up sleeves and work within a small, growing team to build a new high impact business
• Startup experience required or small company experience. Understanding how to work in a small entity that is bring new product to the market
  

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ABOUT US

Beyond the competitive benefits and compensation, Kohler proudly offers a rich history, steeped in creativity and a commitment to our associates and communities. We invite you to learn more about our culture and company at www.kohlercompany.com.
It is Kohler’s policy to recruit, hire, and promote qualified personnel in all job classifications without regard to race, creed, religion, age, sex, sexual orientation, gender identity or expression, marital status, national origin, disability or status as a protected veteran. If, as an individual with a disability, you need reasonable accommodation during the recruitment process, please contact kohlerjobs@kohler.com. Kohler Co. is an equal opportunity/affirmative action employer.

• Secure US and select international regulatory authorization for health/wellness products
• Oversee maintenance of regulatory licenses, registrations and listings
• Work with commercial team to ensure advertising and promotions comply with regulations
• Inject organization with clinical insights and serve as subject matter expert on all clinical, scientific medical and regulatory matters
• Stay abreast of updates to regulatory landscape via intelligence gathering and attendance of tradeshows/workshops
• Act as a liaison to medical advisory board and other key opinion leader