Principal Regulatory & Product Compliance Engineer

About us

Dyson is a global technology enterprise. Were 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 Chicagos 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 Stores across the country.

Were 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 Dysons 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

• Excellent knowledge of the local regulatory authorities and their processes
• An expert in understanding and interpreting industry standards.
• 10 years experience of FDA registration and product approvals including experience with US (e.g. De Novo 510(k) PMA PMA/S etc.) submissions
• 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.
• Excellent collaboration skills.
  

Location: 1330 W Fulton Market Fl 5 Chicago IL 60607

Compensation : $135000 - $169000 annually bonus opportunity

Benefits

At Dyson how we reward you is linked to our high-performance culture. But its about more than salary and bonus. Through a package of financial lifestyle and health benefits we support whatever stage of life youre in and the moments that matter.

Financial benefits:

401K with up to a 4% match

Company paid Life Insurance and AD&D

Flexible Savings Account (FSA) and Health Savings Account (HSA)

Lifestyle benefits:

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

Employee Assistance Program

Dyson Product Discounts

Health benefits:

Multi-Level Healthcare Coverage Options

Vision & Dental Coverage

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 for more information. Dyson is an Equal Opportunity Employer.

#LI-ONSITE

D yson is an equal opportunity employer. We know that great minds dont 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.

Required Experience:

Staff IC