Regulatory Affairs, Compliance, & Approvals Lead

Regulatory Affairs, Compliance, & Approvals Lead Summary Salary : $135,000 - $169,000 annually + bonus opportunity Job Family : Engineering Compliance and Quality Assurance Location : United States - Chicago Office About us Dyson is a global technology enterprise. We’re growing fast and our ambition is huge – more categories, more locations and more people.Dyson launched in the US in 2002, and since then operations have grown exponentially. Our US headquarters is based in Chicago's Fulton Market neighborhood with anadditionalofficelocatedin New York City. We also have employees working in field sales, our service centers, and in our growing number of Dyson Demo Store’s across the country. We're committed to our campus culture and want to have people collaborating, developing, and learning from each other. By having everyone on campus together, we have been able to nurture a fantastic social and dynamic environment. About the role This role is primarily responsible for delivering seamless regulatory approval for Dyson’s highly-innovative and ground-breaking range of products within the region. The role will collaborate closely with the local RDD teams and C&A teams in the hubs engaging in the research of regulatory requirements and delivery of local approvals for our products. The role is responsible for understanding & defining the regulatory requirements within the region and feeding those requirements into the overall product requirements. The role is also responsible for ensuring delivery of local approvals of the products within the various markets within the region. Internally, the role interfaces on a day-to-day basis with category & engineering teams, and with the C&A teams within UK and SEA. The role also includes extensive contact with regional regulators, Certification Bodies, testing laboratories, industry associations and standards bodies. Responsibilities Research, identify and document the local regulatory requirements for proposed products and feed these requirements into the C&A process. Maintain a close understanding of the regional regulatory landscape to identify potential changes, threats & opportunities coming from the regulatory environment. Maintain a good understanding of the potential technology direction of Dyson to understand threats & opportunities within the regulations. Manage & optimize the local approvals processes to ensure the smooth and predictable clearance of Dyson products. Support local approvals testing and registration activities to resolve any issues that might arise. Develop and maintain excellent working relationships with the key players in the local approvals landscape, including: regulatory bodies, certification bodies, testing laboratories and others involved in the approvals process. Engage, where appropriate, with the local industry bodies and standardization committees to understand local trends and influence where possible. Collaborate with other Dyson teams to continuously improve the speed and effectiveness of the approvals processes. Support the preparation, review, and submission of FDA regulatory applications, including De Novo, 510(k), PMA, and other pathways. Implement FDA approval strategies through the product development process to ensure readiness for submission, accounting for regulatory risk and mitigation strategies Ensure alignment with regulatory requirements by engaging with cross functional teams throughout the development process, and through identification and closure of regulatory gaps throughout the development cycle. Ensure compliance with FDA post-market requirements, including review of post-approval manufacturing and design changes. About you Bachelor's degree in science, engineering or related field 5 + years of experience of FDA registration and product approvals, including experience with US (e.g. De Novo, 510(k), PMA, PMA/S, etc.) submissions Excellent knowledge of the local regulatory authorities and their processes An expert in understanding and interpreting industry standards. Experience assessing, compiling, and submitting documentation (development, quality, clinical, etc.) for submission filing Experience with Class I, II, or III medical devices Expertise in FDA compliance and approvals and support of pre and post approval submission activities Graduate or post-graduate degree in science or engineering fields. Excellent creative problem-solving and project management skills. Experience working effectively with cross functional teams and at different levels inside the organization. Ability to adapt plans to changing environments. Detail orientated. Location: 1330 W Fulton Market Fl 5, Chicago, IL 60607 Compensation : $135,000 - $169,000 annually + bonus opportunity At Dyson, how we reward you is linked to our high-performance culture. But it’s about more salary and bonus. Through a package of financial, lifestyle and health benefits, we support whatever stage of life you’re in and the moments that matter. 401K with up to a 4% match Company paid Life Insurance and AD&D Flexible Savings Account (FSA) and Health Savings Account (HSA) Competitive Paid Time Off Benefits including Separate Holiday, Sick, and Vacation Time Pre-tax Commuter Benefits (applicable areas only) Generous Child Care Leave Program Wellness Program Multi-Level Healthcare Coverage Options Company paid Short-Term and Long-Term Disability Dyson is committed to fostering an inclusive and accessible environment that reflects the diversity of the community in which we live. If requested, we will provide reasonable accommodation during the recruitment process for persons with disabilities. Contact us at View email address on click.appcast.io for more information. Dyson is an Equal Opportunity Employer.

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Dyson is an equal opportunity employer. We know that great minds don’t think alike, and it takes all kinds of minds to make our technology so unique. We welcome applications from all backgrounds and employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other any other dimension of diversity. #J-18808-Ljbffr Dyson