Regulatory Affairs Specialist (Fitchburg, WI)

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’.

RTP QA

Regulatory Affairs Specialist (Fitchburg, WI)


Job Description

Evaluate and investigate Pinnacle Radiation Therapy Planning System customer complaints (planning software and computer related).
Complete all required customer complaint related documentation in an accurate, professional and timely manner.
Assist other customer complaint investigators to accurately complete customer complaint investigations and required documentation, as needed.
Present customer complaint investigation facts and details to the Product Safety Committee for those customer complaints that may have a potential safety impact.
Maintain the customer complaint test network with the latest software configurations.
Work closely with other customer complaint investigators to meet department goals.

Philips is an equal opportunity employer.

Job ID 37498
REQUIREMENTS
Required Qualifications:
Experience Requirements:
Preferred Profile

One to five years experience investigating customer complaints in an FDA/ISO regulated environment, preferably with medical device software.
Familiarity with SUN computer workstations and UNIX/Solaris operating system highly desired.
Previous experience with the use of radiation treatment planning software highly desired.
Excellent writing skills.
Good investigational and analytical skills.
Good attention to detail.
Ability to communicate effectively with internal and external stakeholders..
Familiar with common business software applications such as Lotus Notes, MS Word, MS Excel and MS Access.
A.A./B.S Degree required.