Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.
Why join Stryker?
We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
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.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
WHAT YOU WILL DO:
This is a remote position. This person will assist in the timely development and completion of clinical reports, summary documents, package inserts and other documents. May oversee the electronic regulatory submission process. Oversees and provides recommendations for the development of formats and guidelines for documentation. Provides guidance and direction for completion and development of clinical and pre-clinical documents. Ensures effective planning and management of timelines for all aspects of technical documents. Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products. Monitors process of any changes in labeling regulations in the US and/or abroad. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application.
DAY TO DAY:
Lead the initial release and revision of product labels
Study specifications, mockups, drawings, operating procedures to integrate and delineate in product documents
Observe product demonstrations, development activities to determine operating procedures and detail
Manage content translation with vendors and internal teams
Participate in cross-functional design reviews
Apply corporate, quality, and regulatory requirements to assigned work. Also support/lead process improvement initiatives
Develop and maintain individual deliverable timelines
Support multiple development projects concurrently
Travel as necessary to support project meetings, training, supplier visits, etc.
WHAT YOU NEED:
At least 4 years of regulated industry experience in a label content management role
1+ years of Prisym experience for 2-D Label management (other 2-D Labeling software will be considered
Proficiency in MS product suite (Word, Outlook, Excel etc.),
Strong communication skills both written and verbal
NICE TO HAVES:
Bachelors Degree in English, Communications or related
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