Associate Principal Regulatory Specialist

Reposted 8 Days Ago
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Chicago, IL, USA
In-Office
124K-155K Annually
Senior level
Appliances • Manufacturing
The Role
The Associate Principal Regulatory Specialist manages US OTC regulatory compliance, serves as FDA contact, and oversees product submissions and labelling, ensuring regulatory adherence.
Summary Generated by Built In
 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. 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.   

At Dyson we are encouraged to think differently, challenge convention and be unafraid to make mistakes. We’re creative, collaborative, practical and enthusiastic. But most of all we’re hugely passionate about what we do. 

We push the barriers of engineering every day and challenge convention to develop world class products. To be successful in this, we must design products for compliance. This means collaborating at an early stage with design teams where we remove barriers to the global market.

About the role:  

The Global Product Regulations and Compliance team provide expertise and advice to support product development to obtain global market access. We are seeking an experienced US-based regulatory professional with strong OTC drug expertise and solid cosmetic regulatory knowledge to serve as the US regulatory subject matter expert within our Global Regulatory team 

This is a senior individual contributor role with primary accountability for US OTC regulatory compliance and FDA interface. The successful candidate will act as Dyson’s official US regulatory contact and US Agent, providing authoritative guidance across the US portfolio while independently managing assigned projects from development through launch and post-market support. 

While the primary focus is the Americas, the role will also contribute to global project regulatory delivery in partnership with regional regulatory colleagues. This role is office-based in Chicago and reports to the Senior Regulatory Manager (UK).

 
Responsibilities:
 

US OTC Regulatory Compliance (Primary Focus) 

  • Act as primary FDA contact and US Agent. 

  • Serve as the internal subject matter expert for US OTC regulatory requirements. 

  • Interpret and apply OTC Drug Monographs, the FD&C Act, and applicable sections of 21 CFR. 

  • Determine product classification (cosmetic vs OTC) and advise on compliant claims positioning. 

  • Develop, review, and approve Drug Facts labelling. 

  • Manage establishment registration and SPL product listing submissions. 

  • Support regulatory correspondence and inspection readiness activities. 

  • Oversee post-market compliance obligations, including serious adverse event reporting. 

US Cosmetic Regulatory Compliance 

  • Ensure compliance with US cosmetic regulations, including MoCRA requirements. 

  • Review ingredient compliance and safety substantiation. 

  • Support cosmetic facility registration and product listing requirements. 

  • Provide regulatory guidance on cosmetic labelling and claims. 

Project Ownership & Team Contribution 

  • Be the Americas regional regulatory specialist for the global team 

  • Independently manage assigned global regulatory projects end-to-end with peer review from regional regulatory specialists 

  •  Manage the product information files and ensuring labelling is compliant. 

  • Complete registration/ notification where required.  

  • Ensure that the compliance requirements are clearly communicated to teams 

  • Participate in improving project delivery activities by proposing solutions and presenting concepts for evaluation while participating in the evaluation of others. 

  • Own/contribute to Team transformation initiatives & change projects 

  • Mentoring other team members where required. 

Regulatory Intelligence 

  • Understanding of the different avenues for intelligence gathering in the Americas. 

  • Maintain relationships with key third parties including suppliers, consultants, regulatory bodies, laboratories and trade associations for the Americas. 

  • Proven ability to communicate unambiguous regulatory concepts to the global regulatory and compliance team, global R&D, the regional business and external parties 

About you
  • Minimum 8 years’ experience in regulatory affairs, including substantial, recent responsibility for US OTC drug regulatory compliance (FDA—strategy, submissions, launch, and post-market support are all required). Experience with US cosmetics regulation. (MoCRA) is strongly preferred.

  • Proven ownership of US FDA and MoCRA compliance, with hands-on experience interpreting and applying OTC monographs, 21 CFR, and US cosmetics law, including successful product launches from development through post-market support.

  • Effective at explaining and championing complex regulatory requirements with cross-functional teams, external partners, and regulators at different levels. You handle constructive challenge well and can influence decisions at all levels.

  • Experience working flexibly across categories (OTC, cosmetics, biocides, detergents), and comfortable stretching outside core expertise as Dyson’s portfolio evolves.

  • Highly organized with a track record of managing complex projects. Meticulous with records, committed to deadlines, and able to juggle competing tasks without missing details.

  • Experience collaborating with teams and stakeholders based in different regions and time zones, adapting your style as needed.

  • Comfortable operating as a self-starter as the region’s solo subject matter expert, while closely collaborating and communicating with a global, matrixed team.

Compensation: $124,000 - $155,000 annually + bonus opportunity
 

Benefits:

At Dyson, how we reward you is linked to our high-performance culture. But it’s about more than 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.

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
#LI-Onsite

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.

Skills Required

  • Minimum 8 years experience in regulatory affairs
  • Strong project and document management skills
  • Proven ownership of US FDA and MoCRA compliance
  • Effective at explaining complex regulatory requirements
  • Ability to manage multiple projects

Dyson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Dyson and has not been reviewed or approved by Dyson.

  • Healthcare Strength Medical, dental, and vision offerings are broad, paired with company‑paid life and disability coverage, plus EAP, backup care, and wellness incentives. Employer‑funded healthcare dollars and premium‑discount or Lifestyle Spending Account options further enhance coverage value.
  • Retirement Support A 401(k) with a company match is consistently advertised on U.S. postings. This provides predictable retirement support across roles.
  • Wellbeing & Lifestyle Benefits Wellbeing programs, commuter benefits, and notable product discounts supplement core coverage. Wellness incentives and a Lifestyle Spending Account expand lifestyle support beyond medical plans.

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The Company
Chicago, Illinois
13,356 Employees
Year Founded: 1993

What We Do

At Dyson we are focused on solving the problems that others have ignored; solving them first using our technology and ingenuity. In order to achieve this we need to pioneer technologies that are different and authentic. This is the core of what we do and who we are. We must strive to create the future, every single day by developing new things, different things, things that go against the grain with a diverse and global team of ingenious minds. Dyson employs over 14,000 people and is present in more than 80 countries. And while we are growing fast we want Dyson to remain a start-up in spirit with the freedom of experimentation and learning, constantly reinventing our products as well as reinventing how we work, how we sell and how we support our owners. At the same time we are working through the James Dyson Foundation, James Dyson Award and Dyson Institute to inspire future engineers and pioneering a new approach to engineering education. Underlining everything we do in this diverse environment is the need to always show respect, supporting each other as one team to overcome whatever challenges we encounter. We drive empowerment, development and equality in an inclusive environment for our people around the world. The future doesn’t just happen, we look to make it happen, to achieve leaps through pioneering new ideas

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