Post Market Regulatory Affairs Compliance Representative
Location: Tempe, Arizona
Internal Number: R455187
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Why engineering at Stryker?
At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.
The RA Compliance Representative is responsible for administrative duties associated with customer complaint submissions, management of quality complaint data and customer communications. This position supports quality investigators and serves as the point of contact for field personnel inquiries regarding complaint investigations.
§Supports Complaint Intake including phone support, email and web submissions.
§Responsible for Customer and Field follow up to ensure CFR part 820.198 requirements are met.
§Ensures documentation is complete and accurate in the TrackWise Complaint Handling System.
§Generate shipping labels for complaint device returns and conducts follow up to ensure devices are returned timely.
§Creates and distributes complaint device letters to customers and field representatives.
§Completes quality credit requests in JDE.
§Supports the lab as needed to check in devices and upload photographs of devices.
Various administrative duties as assigned
§Associate's degree preferred.
§1-3 years related work experience; experience in medical device industry and/or experience in medical device complaint handling preferred.
§Excellent written and verbal communication skills
§Background in customer service and/or quality assurance desired
§Excellent time-management, documentation, and organizational skills
§Exceptional computer skills
§Highly organized and detail-oriented
§Team-oriented and motivated
§Strong work ethic and dependable
§Proficient in MS Office applications and strong typing skills required
§Experience with Access or comparable database preferred
§Familiar with ISO standards and FDA regulations for medical devices preferred.
Familiar with standard concepts, practices and procedures within the medical device field preferred.
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK