Senior Regulatory Affairs Specialist (Remote) (R461667)
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
Stryker’s Neurovascular Division is seeking to hire a Senior Regulatory Affairs Specialist to support the International Regulatory Affairs team. This role will be in Fremont, CA or remotely anywhere in the United States.
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.
• Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
WHAT YOU WILL DO:
The Senior Regulatory Affairs Specialist will support regulatory processes and procedures for international change control coordination. The primary focus of this position is facilitating assessing changes to commercialized product to determine worldwide regulatory impact of the change while facilitation documentation to support regulatory pathway for the change and communicating change impact to affected organizations across Stryker Neurovascular. This Senior Regulatory Affair Specialist will report to the Senior Regulatory Affairs Manager, EMEA & LATAM.
Monitor and drive change controls within Regulatory International team to approval and closure by tracking action items, impact assessments, regulatory approvals, and implementation activities ensuring timelines are met to support regulatory submissions and/or manufacturing/supply deliverables.
Perform detailed review of change controls (including countries assessments mark-ups) for accuracy, robustness, and completeness.
Present/discuss pending and/or delayed change actions at monthly regulatory international submissions-team meetings for each product current Detailed Regulatory Assessment (DRA).
Identify causes of documentation and change control process rework, delay and implement actions to streamline process improvement actions.
Gather change control supporting documentation in an organized and sustained manner to be provided to Regulatory Affairs International teams for regulatory submissions as applicable.
Provides regulatory support to other Regulatory Affairs International special projects to facilitate cross-functional leverage and regulatory deliverables.
Uses existing project management and data analysis tools and develops/implements new tools as needed.
Performs responsibilities required by the Quality System and other duties as assigned or requested.
WHAT YOU NEED:
Bachelor’s degree required. Bachelor’s degree in engineering or science - preferred
3+ years regulated work experience, preferably in medical devices - required
1+ years regulatory affairs experience - preferred
Proficient with excel, SharePoint, powerbi, tableau - required
Thorough understanding of international medical device regulations - preferred
Experience with change control, change management - preferred
This job may be performed remotely from anywhere in the United States, except that this job may not be filled or performed in Colorado.
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