Head of Regulatory - Kohler Ventures

Work Mode: Hybrid

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

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 Head of Regulatory Affairs to own the regulatory, quality, and clinical strategy forKohler Ventures. The position will be integral to bringing Kohler’s firstregulated health and wellness product to market. The ideal candidate will haveexperience in obtaining FDA clearance for technologically advanced digitalhealth and wellness products in a startup or innovative business unit of anestablished company. The role will engage with regulatory bodies, conductclinical studies and trials, file regulatory submissions, and ultimately obtainsuccessful FDA clearance for the portfolio of Kohler Ventures health andwellness products.

Inthis roleatKohler Ventures you will:

• ReportdirectlytoKohlerVenturesManagingDirector andleadcreationofregulatorystrategyfor the health product portfolio
• SecureUSandselectinternationalregulatoryauthorizationforhealth/wellnessproducts
• Leadthe quality,clinicalandregulatoryteam(includingexternalconsultantsand CROs)
• Overseemaintenanceofregulatorylicenses,registrationsandlistings
• Workwithcommercialteamtoensureadvertisingandpromotionscomplywithregulations
• Injectorganizationwithclinicalinsightsandserveassubjectmatterexpertonallclinical,scientific medical and regulatory matters
• Stayabreastofupdatestoregulatorylandscapeviaintelligencegatheringandattendanceof tradeshows/workshops
• Actasa liaisontomedicaladvisoryboardandotherkeyopinionleaders

Skills/Requirements

• 10 yearsofregulatoryexperienceinhealthcare
• ABachelor’sdegreefromareputededucationalinstitution;MD/JD/Ph.D.orotheradvanced degrees highly preferred
• Must have a successful record of taking a new product in development through its first regulatory approvalsfromtheFDA(510(k)andDeNovo)intheUS;internationalexperience,especiallyin China, preferred
• Demonstratedexperiencecreatingresearchstrategiesandperformingclinical trialsworkingwith CROs
• Commercial experience supporting bringing new product to market
• Extensiveexperiencesettingupandworkingwithqualitymanagementsystems(QMS);withdeep knowledge of associated standards and compliance requirements
• RegulatoryexpertiseinSoftwareasaMedicalDevice(SaMD)
• Strong experienceprovidingregulatorysupporttoproductand engineeringteamsacrossallstagesofthe product development lifecycle. Significant experience collaborating with Product Engineering to help them meet regulations while incubating at the speed of a startup.
• Capableofworkingincross-functionalenvironmentanddevelopingrelationshipswith medical advisory board members and regulatory bodies
• Desiretorollupsleevesandworkwithina small,growingteam tobuild anewhighimpactbusiness
• Startup experience required or small company experience. Understanding how to work in a small entity that is bring new product to the market
• 25% of travel, both domestic and international

#LI-NR1

#LI-Hybrid

Applicants must be authorized to work in the US without requiring sponsorship now or in the future.

The approved base salary range for this position is $176,500 - $226,950. 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 $204,740 - $263,262 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 .