Associate Principal Regulatory Specialist

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. 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.

At Dyson we are encouraged to think differently challenge convention and be unafraid to make mistakes. Were creative collaborative practical and enthusiastic. But most of all were 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 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 Dysons 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 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 (FDAstrategy 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 Dysons 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 regions solo subject matter expert while closely collaborating and communicating with a global matrixed team.

Compensation: $124000 - $155000 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


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