Full-Time

Director of Regulatory Compliance-Oral Healthcare

Posted on 6/6/2026

Philips

Philips

Healthcare technology for diagnosis, care, wellness

Compensation Overview

$172.2k - $275.5k/yr

+ Annual Incentive Bonus + Sales Commission + Long-Term Incentives

No H1B Sponsorship

Bothell, WA, USA

Hybrid

Office role; onsite 3 days per week required.

Category
Legal & Compliance (1)
Required Skills
FDA Regulations
Requirements
  • A minimum of 12+ years' experience in Regulatory Affairs within FDA regulated Medical Device/Consumer electronics environments.
  • A minimum of 6+ years as a functional/strategic leader, including mentoring, training, succession planning, hiring, performance management, technical/professional development of team members.
  • Demonstrated 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).
  • US work authorization is required for employment.
  • Must be able to reside in or within commuting distance to Bothell, WA.
  • Company does not provide relocation benefits for this position.
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.
Desired Qualifications
  • Master’s degree/Master of Business Administration desired

Philips develops health technology across professional medical devices, connected care, and consumer health products. Its offerings include diagnostic imaging and image-guided therapy, patient monitoring and clinical informatics, and everyday wellness products like oral and personal care. The company increasingly delivers integrated solutions through a Healthcare-as-a-Service subscription model and long-term partnerships with hospitals and health systems. Its aim is to improve people’s health and well-being by making advanced health technology easier to access and integrate into care.

Company Size

N/A

Company Stage

IPO

Headquarters

Andover, Minnesota

Founded

1891

Simplify Jobs

Simplify's Take

What believers are saying

  • Remote patient monitoring growth expands demand for Philips' connected-care and home-care offerings.
  • The 2.5 billion lives target supports scale-focused partnerships in underserved and developed markets.
  • Hospital deployments like HealthAlliance validate demand for faster imaging and tighter monitoring integration.

What critics are saying

  • Respironics recall settlements and remediation continue pressuring cash flow and reputation.
  • Imaging rivals like GE HealthCare compress pricing and complicate large hospital contract wins.
  • Remote-monitoring competitors from Medtronic and Abbott threaten Philips' subscription-style connected-care adoption.

What makes Philips unique

  • Philips spans diagnosis, treatment, connected care, and personal health across the care continuum.
  • It leads in diagnostic imaging, image-guided therapy, patient monitoring, and health informatics.
  • Its strategy emphasizes integrated solutions and long-term partnerships, not standalone device sales.

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Benefits

Health Insurance

401(k) Retirement Plan

401(k) Company Match

Unlimited Paid Time Off

Health Savings Account/Flexible Spending Account

Company News

HIT Consultant
Apr 12th, 2024
Philips Respironics Reaches Final Agreement With Us Regulators On Sleep Apnea Device Recall

<img src="https://hitconsultant.net/wp-content/uploads/2024/04/Philips.webp" alt="Philips Respironics Reaches Final Agreement with US Regulators on Sleep Apnea Device Recall. " class="wp-image-78777" srcset="https://hitconsultant.net/wp-content/uploads/2024/04/Philips.webp 700w, https://hitconsultant.net/wp-content/uploads/2024/04/Philips-300x161.webp 300w, https://hitconsultant.net/wp-content/uploads/2024/04/Philips-290x155.webp 290w" sizes="(max-width: 700px) 100vw, 700px">What You Should Know: – Philips Respironics, a subsidiary of Royal Philips, has finalized a consent decree with the US Department of Justice (DOJ) and Food and Drug Administration (FDA) to address issues raised during a 2021 inspection of a Philips facility in Pennsylvania.– The agreement focuses on Philips Respironics’ operations in the US, particularly regarding the recall of certain sleep and respiratory care devices.– The company’s focus will now be on completing remediation efforts, ensuring patient safety, and regaining regulatory approval to resume sales of new devices in the US.Focus on Remediation and ComplianceThe consent decree outlines a roadmap for Philips Respironics to:Prioritize Recall Remediation: Philips will continue efforts to remediate millions of sleep apnea and respiratory care devices recalled in June 2021 due to potential health risks associated with degraded sound abatement foam.Independent Oversight: Independent experts will be brought in to review recall remediation efforts and ensure Philips Respironics’ business operations comply with FDA regulations.Continued Patient Support: Philips Respironics can continue servicing existing devices in the hands of patients and healthcare providers. Additionally, they can sell accessories, consumables, and replacement parts for these devices.Sales Restrictions Remain in USThe FDA has not yet authorized Philips Respironics to resume sales of new CPAP, BiPAP, or other respiratory care devices in the US. This restriction will remain in place until Philips meets the requirements outlined in the consent decree.Global Sales Continue with RestrictionsPhilips Respironics can continue to sell new devices, accessories, consumables, and replacement parts outside the US,  subject to specific requirements.Safety of Devices with New Foam ConfirmedPhilips Respironics has conducted tests on devices using a new silicone sound abatement foam and found no safety issues. Patients can continue to use these devices following the instructions for use.Financial ImpactPhilips anticipates incurring costs associated with remediation activities and profit disgorgement related to US sales. These costs are estimated at 100 basis points in 2024.  The company’s previously announced 2023-2025 financial outlook remains unchanged,  already factoring in the consent decree. “Strengthening patient safety and quality remains Philips’ highest priority and the increased scrutiny will help us to improve even more

Goodrich Pharmacy
Jan 29th, 2024
Phillips Suspends U.S. Sales of CPAP, Ventilator Machines After Recall

Following a recall of millions of its breathing machines that began in mid-2021, Phillips Respironics announced Monday that it would halt sales of all such machines within the United States.

Parker Waichman LLP
Mar 23rd, 2023
Sleep Apnea Patients Suffer While Waiting To Receive Their Repaired Philips CPAP Machines

In June of 2021, Philips began a recall of over five million of its breathing devices due to toxic fume and substances emanating from the devices’ sound abatement foam.

Digital Journal
Jan 13th, 2023
Ultrasound Market Share | Market | Report | Analysis 2032 | Key Players: Fujifilm Holdings Corporation, Analogic Corporation, Siemens Healthcare among others

February 2019 – Koninklijke Philips launched the EPIQ Elite ultrasound system in the market.

VentureBeat
Oct 26th, 2022
Philips Norelco Brings Movember To Roblox With Shavetopia

Register now for your free virtual pass to the Low-Code/No-Code Summit this November 9. Hear from executives from Service Now, Credit Karma, Stitch Fix, Appian, and more. Learn more. Philips Norelco is creating an interactive metaverse experience called Shavetopia in Roblox, based around the Movember trend. For anyone who doesn’t know what that is, Movember is where people grow facial hair for the entire month of November. The portmanteau comes from adding the word mustache to the name of the month