Director of Regulatory Compliance-Oral Healthcare jobs in United States
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Philips · 22 hours ago

Director of Regulatory Compliance-Oral Healthcare

Philips is a health technology company dedicated to improving healthcare access for everyone. The Director of Regulatory Compliance will formulate and execute global regulatory strategies to ensure alignment with business objectives while leading the regulatory compliance team and managing relationships with regulatory bodies.

B2BConsumer ElectronicsElectronicsLightingWellness
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Responsibilities

Develop global regulatory strategies by creating and implementing regulatory roadmaps aligned with market trends, legislation, product marketing objectives and staying current on evolving regulations to advise senior leadership on strategic decisions
Be a regulatory authority liaison, acting as the business unit contact with regulatory bodies, ensuring clear communication and fostering relationships to influence decisions and secure approvals
Lead our regulatory compliance team by providing guidance, managing talent, and driving succession planning and growth while maintaining compliance and achieving organizational goals
Ensure compliance across the product lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access
Drive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards

Qualification

Regulatory AffairsGlobal Regulatory KnowledgeLeadership ExperienceFDA RegulationsStrategic PlanningCommunication SkillsRelationship BuildingTeam Management

Required

12+ years' experience in Regulatory Affairs within FDA regulated Medical Device/Consumer electronics environments
6+ years as a functional/strategic leader, including mentoring, training, succession planning, hiring, performance management, technical/professional development of team members
Global Regulatory Domain knowledge/expertise in overseeing the preparation/submission of regulatory filings/documentation, global product registrations/approvals and leading others in global regulatory matters of diverse product categories - Class I medical device, consumer goods and cosmetics
Ability to communicate, influence and build relationships with Internal/External Stakeholders, regulatory authorities and industry organizations at all levels
Bachelor's Degree (Required)
Ability to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
US work authorization is a precondition of employment
Must reside in or within commuting distance to Bothell, WA

Preferred

Master's degree/MBA desired

Benefits

Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement

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