Regulatory Affairs Specialist jobs in United States
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Philips · 9 hours ago

Regulatory Affairs Specialist

Philips is a health technology company dedicated to improving access to quality healthcare. The Regulatory Affairs Specialist role involves supporting the Oral Healthcare business unit by advising on regulatory strategies, ensuring compliance for new products, and managing regulatory submissions.

B2BConsumer ElectronicsElectronicsLightingWellness
badNo H1BnoteU.S. Citizen Onlynote

Responsibilities

Assisting with implementation of global regulatory and roadmaps through understanding the Competitive market landscape and product Marketing strategy
Advising product design teams on regulatory strategy and requirements for specific new products/solution
Regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance. Review and approve engineering changes and labeling for regulatory compliance
Supporting the development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations
Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions. Identify potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project

Qualification

Regulatory affairs experienceGlobal regulationsCosmetic formulation chemistryRAPS RAC certificationProject management skillsStakeholder communication skillsAnalytical skills

Required

You have a Bachelor's or Master's degree in Chemistry, Chemical Engineering, Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law or equivalent
2+ years with Bachelor's OR Minimum 1 year with Master's of experience in regulatory affairs, medical device and/or cosmetic product compliance, quality compliance, product stewardship, chemical safety
You understand cosmetic formulation chemistry (emulsions, surfactants, preservatives, actives), have knowledge of global cosmetic regulations (EU, U.S., UK, Canada, China, ASEAN) and strong analytical, project management, and stakeholder communication skills
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell WA

Preferred

Prefer 5+ years of experience
RAPS RAC certification desired

Benefits

Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement
Comprehensive Philips Total Rewards benefits program

Company

Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.

Funding

Current Stage
Public Company
Total Funding
$4.23B
Key Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M

Leadership Team

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Neil Mesher
CEO and SVP, UK and Ireland
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Company data provided by crunchbase