International Regulatory Affairs Coordinator

COVID-19 vaccination requirements

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, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

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 regulatory affairs/quality assurance 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 Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Essential Functions:

• Responsible for responding to requests for documentation to support global product registration in China and coordination with Stryker affiliates and other global authorities to facilitate product registration.
• Responsible for developing, coordinating and obtaining legal documentation required for US and global registration including Certificates of Foreign Government, Free Sales Certificates and FDA listing for yearly registration and new product introduction (FURLS administration).
• Builds strong relationships with global regulatory affairs teams
• Supports change control notification communication as applicable
• Develops basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures
• Interacting with global content management system (Global RADAR)
• Communicating with internal global regulatory affairs groups
• Uploading change control notification documentation to the content management system (Global RADAR)
• Coordination and support of technical and scientific regulatory activities required for international registration
• Work from verbal and/or written instructions
• Updating and maintaining paper/electronic document archival systems
• Assisting in the preparation of routine reports and regulatory agency communications
• Maintaining regulatory paper and electronic files

Qualifications:

• Excellent interpersonal, written English and oral communication skills
• Knowledge or proficiency of Mandarin language highly desirable.
• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
• Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.).
• Excellent organizational, problem-solving, and analytical and time management skills
• Self-motivated.
• Proficient with Microsoft Office and ability to learn corporate systems
• Ability to deal effectively with a diversity of individuals at all organizational levels.
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines

Education & Experience:

• High School diploma or equivalent
• Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred.
• 2 year’s regulatory experience in the medical device industry.
• Previous experience in legal, technical, or medically related area preferred.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

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 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