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Regulatory Affairs Specialist
 Full Time, Employee |
 bothell, WA 98021 |
We simplify healthcare by focusing on the people in the care cycle – patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.
AED Regulatory Department
Job Description
Assist with the management and execution process for international registrations including providing guidance with localization and labeling requirements.
• Review international shipment requests to ensure regulatory requirements are met.
• Work with Customer Solutions team with complaint handling, analysis and regulatory reporting requirements (US and international).
• Work with project teams and support development of Regulatory Plans. Includes device submissions, technical file preparation, design history file creation, and ongoing product regulatory support.
• Participate as needed with field actions including assisting with the creation of plans and reports, action execution, and regulatory agency interaction.
• Review and approve advertising and promotional materials
Requirements
•BS engineering, science or technical field
•5 plus years of regulatory experience in the medical device industry
•Experience with MDR’s, CAPA.
•Quality system standards and regulations ISO 13485 and 21CFR Part 820
•Experience with filing submissions and international regulatory process.
•Experience with ISO 14971 and conducting product risk assessments
•AED & Clinical background desirable.
•Exceptional documentation skills
•Skill with MS Excel, MS Access, (SAP a plus)
Philips is an equal opportunity employer.
Job ID: 61352
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