Philips · 11 hours ago
Principal Regulatory Affairs Specialist
Bothell, WA
Full-time
Onsite
Senior Level, Lead/Staff
$129K/yr - $206K/yr
8+ years expPhilips is a health technology company dedicated to improving healthcare access for everyone. The Principal Regulatory Affairs Specialist will lead regulatory oversight for new product development projects, ensuring compliance with FDA and other regulatory standards while mentoring regulatory professionals within the organization.
B2BConsumer ElectronicsElectronicsLightingWellness
Responsibilities
Leads business critical new product development projects and provide regulatory oversight to maintain lifecycle ensuring that requirements are maintained. Identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects teams and RA management. Mentor and coach Philips Ultrasound regulatory professionals in their development
Will negotiate directly with regulatory enforcement entities (e.g. governmental agencies, notified bodies, etc.) on regulatory filings at the reviewer level. All significant issues will be reviewed with the RA management
Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained. Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols
Providing guidance on current, new and updated Regulatory compliance procedures globally, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X, ISO 13485 and ISO 14155, China NMPA, Canadian CMDCAS, Japan JPAL, compliance with FDA’s guidance documents, and including requirements that are relevant to the overall Philips Ultrasound priorities globally
As needed, you will represent Philips Ultrasound Regulatory Organization in both internal audits and external audits by various key market regulatory agencies, including inspections and surveillance visits by Notified Body. May represent Philips in an international committee chartered to develop an applicable standard
Qualification
Required
A minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device/HealthTech product environments
Strong knowledge of US FDA, China NMPA, CE Marking, EU MDD/MDR, JPAL, Canadian CMDCAS etc. with proven/successful preparation and submission of Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally
Able to work in a large, matrixed organization and collaborate with globally dispersed partners/team members
A minimum of a Bachelor's Degree in Regulatory Affairs, Engineering, Life Sciences or comparable disciplines (Required)
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
Preferred
Experience with Software as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired
Master's degree, RAC Certification desired
Benefits
Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement
Company
Philips
Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.23BKey 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
Neil Mesher
CEO and SVP, UK and Ireland
Recent News
2026-01-22
2026-01-22
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