Regulatory Affairs Specialist (Seattle, WA)

Purpose:
Philips Medical Systems

A leader in Healthcare, Philips Medical Systems is one of the world’s top three medical device companies. Our mission is to improve the quality of people’s lives.

Our focus areas include imaging systems, customer services, information and monitoring systems. We enjoy a number one position in several of these including X-ray, cardiovascular ultrasound, patient monitoring and automatic external defibrillators. Our HeartStart Home Defibrillator brings life-saving technology to consumers in their own homes, where the majority of sudden cardiac arrests occur. It’s just one of the many ways we deliver ‘advanced’ technology that is ‘designed around you’ and ‘easy to experience’.

Quality & Regulatory

Regulatory Affairs Specialist (Seattle, WA)

Job Description

Responsibility for United States and Canadian regulatory clearance/approvals.
Responsibility for compliance with the Medical Device Directive and technical file preparation.
Participation on product development teams.
Review and approval of product labeling and advertising materials.

Philips is an equal opportunity employer.

Job ID 37645
REQUIREMENTS
Required Qualifications:
Experience Requirements:
Preferred Profile

Bachelor's degree
5 years experience with medical device manufacturer authoring 510(k), IDE, Health Canada license applications and technical file preparation.

Travel Percentage: 0%