Head Of Safety, Quality & Regulatory- Oral Health Care
Philips
Bothell, WA, USA
Base: $181,000 to $288,960; bonus/equity: annual i...
Fully remote
15+ years in product design quality
Iso 13485 medical device experience
Iso 9001 certification knowledge
Philips is seeking a Head of Safety, Quality & Regulatory for their Oral Health Care division in Bothell, WA. This leadership role requires extensive experience in quality and regulatory affairs within the medical device sector, focusing on compliance and product lifecycle management
Job Summary
The role is accountable for overseeing product, hardware, and software quality, risk management, and regulatory activities throughout the entire product life cycle.
Candidates must have extensive experience in both ISO 13485 Medical Device/Technology and ISO 9001 standards with a focus on FDA Class I medical devices.
Employees are eligible to participate in a comprehensive Philips Total Rewards benefits program which includes generous PTO, a 401k match up to 7%, and stock purchase plans.
Matching Summary
Match Score: 85
Philips is seeking a Head of Safety, Quality & Regulatory for their Oral Health Care division in Bothell, WA. This leadership role requires extensive experience in quality and regulatory affairs within the medical device sector, focusing on compliance and product lifecycle management.
Salary
Base: $181,000 to $288,960; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Generous PTO, 401k match up to 7%, HSA contribution, stock purchase plan, education reimbursement
Skills & Requirements
Must-have
15+ years in Product Design Quality
ISO 13485 Medical Device experience
ISO 9001 certification knowledge
FDA Class I medical device design
Risk Management FMEA ISO 14971
Biocompatibility ISO10993-1 expertise
Nice-to-have
Advanced statistics capabilities
Strategic team leadership skills
Continuous improvement culture
Global regulatory strategy development
Talent development and mentoring
Key Requirements
Minimum 15+ years experience in Product Design Quality
Bachelor's Degree in Quality or Engineering
US work authorization required without sponsorship