at Stryker in Cary, Illinois, United States
Job Description
Why RA/QA at Stryker?
Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker’s RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team : https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
We are proud to be named one of 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; healthcare; insurance benefits; retirement programs; stock based 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.
We are currently seeking a Senior R egulatory Affairs Specialist to join our Medical division. This is a hybrid role based in Cary, IL.
Who we want
+ 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, information, use cases, and industry analyses to develop best practices.
+ Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
What you will do
As the Senior Reg ulatory Affairs Specialist , you will provide information used to evaluate proposed products for regulatory classification and jurisdiction. You will research requirements (local, national, international), applicable guidance and standards and options of regulatory submissions, approval pathways, and compliance activities.
+ Identifies information sources and resources for local, regional, and global regulations
+ Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information
+ Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.)
+ Assists in the development of regulatory procedures and SOPs
+ Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations
+ Organizes materials from preclinical and clinical studies for review and assists in the review process
+ Compiles and organizes materials for pre-submission reports and communications
+ Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies
+ Tracks the status of applications under regulatory review and provides updates to the regulatory team
+ Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
+ Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
What you need
+ Bachelors Degree in Engineering, Science, or related required
+ Masters Degree in Regulatory Science preferred
+ 2+ yrs experience
+ Ability to create clarity and direction amid complexity and develops solutions for self, colleagues, and the organization
+ Ability to seek out diverse ideas, opinions, and insights, and applies them in the workplace
About Stryker
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com (http://www.stryker.com.)
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
