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Work Mode: Hybrid

Location: Hybrid, 2-3 days/week onsite in New York City, NY

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.

W e are seeking a Compliance and Regulatory Lead (Product Compliance Manager - internal title) to own the regulatory, quality, and clinical strategy for Kohler Ventures. The position will be integral to bringing Kohler’s first regulated health and wellness product to market. The ideal candidate will have experience in obtaining FDA clearance for technologically advanced digital health and wellness products in a startup or innovative business unit of an established company. The role will engage with regulatory bodies, conduct clinical studies and trials, file regulatory submissions, and ultimately obtain successful FDA clearance for the portfolio of Kohler Ventures health and wellness products.

Inthis roleatKohler 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

We will consider applicants requiring sponsorship for this opportunity.

The approved base salary range for this position is $142,350 - $181,900. The actual base salary offered to a candidate may be higher than the approved range. This will vary depending on a variety of factors including the candidate’s experience, their education, and the work location. This position is subject to a 16% Area Salary Differential (Cost of Living Adjustment) in the NYC metro area. The approved base salary range including ASD for this position is $ 165,126 - $ 211,004 depending on location. In addition, this position is eligible for a performance bonus and a special project incentive. Available benefits include medical, dental, vision and 401k.

Why Work at Kohler Co.?

Kohler Co.'s mission is to contribute to a higher level of gracious living for those who are touched by our products and services. We understand that it takes investment in our associates’ development to make that happen.So, we offer ongoing investment in each individual’s personal development and the opportunity to collaborate with others across functions and roles at Kohler.

In addition to the investment in your development, Kohler offers a benefits package including a competitive salary, health, vision, dental, 401(k) with company matching, and more!

• Important update for candidates applying to roles within Kohler Energy, including Power Systems, Engines, Home Energy, Kohler Uninterruptible Power, Clarke Energy, Curtis Instruments, and Heila Technologies. On November 6, Kohler Co. announced the strategic decision to establish Kohler Energy as a separate, independent business with Platinum Equity as the majority investment partner. Kohler will continue to stay invested in the Energy business following the closing and remains committed to supporting the acceleration of long-term growth strategies for both organizations. Talent and operational transition plans are underway, and Kohler Co. and Platinum Equity expect the agreement to close in the first half of 2024.Thank you for your interest in joining our growing team as we embark on the next phase of growth!

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.

We invite you to learn more about equal employment opportunity by reviewing the Federal EEO is the Law and the EEO is the Law Supplement .