Senior Regulatory Affairs Specialist- Post Market Surveillance (Remote)

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 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 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. 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Stryker is seeking to hire a Senior Regulatory Affairs Specialist- Post Market Surveillance for the spine division to work remotely anywhere in the United States.

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 Regulatory Affair’s 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. 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

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 managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.

• Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

WHAT YOU WILL DO:

As senior post market surveillance specialist, you will have the opportunity to become Stryker Spine’s expert and process owner, leading post market surveillance regulatory and compliance data driven processes and initiatives. In addition to maintenance of existing post market surveillance data activities, such as product trending and product historical performance reports, you will also work in a dedicated, cross functional and energetic project team implementing the EU MDR (Medical Device Regulation) requirements within the spine division. If you’re looking to make a positive impact on our products and processes and like to work on diverse projects and initiatives, this is a great opportunity!

• Responsible for leading, coordinating, planning, and maintaining post market surveillance data related initiatives and processes.

• Responsible for leading, creating and maintaining post market surveillance documents and reports according to regulations (EU) 2017/745, MDD guideline 92/42 / EEC (Post Market Surveillance Report / Periodic Safety Update Reports), ISO 13485 and FDA.

• Responsible for actively monitoring and trending product performance (collection, evaluation and analysis of complaint data, adverse events, recalls, feedback, etc)

• Creating and maintaining different dashboards/ data visualization using BI tools to support different initiatives on the post market surveillance teams

• Act as SME for Post Market Surveillance data analytics and processes by leading and developing PMS data requirements and processes and owning and implementing internal procedures to comply with global post market surveillance regulations.

• Work cross-functionally with various departments (medical affairs, research and development, risk management, clinical affairs) to ensure PMS processes are adequately implemented.

• Act as subject matter expert in internal and external audits

WHAT YOU NEED:

• A Bachelor’s Degree required. (B.S or B.A) in Engineering, Science or equivalent focus is preferred.

• 3+ years relevant work experience in an FDA or regulated industry required.

• 1+ years Medical Device or Pharmaceutical experience preferred.

• Advanced Master’s degree or Master of Science in Regulatory Affairs Preferred.

• Working experience using analytical or business intelligence tools (Power BI, Tableau, R/ Pthyon/SQL/Alteryx) preferred.

• Familiar with regulatory requirements (euMDR, 21 CFR, MDSAP) preferred

• Spinal/Orthopedic medical device product experience 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.

Our benefits

Our total rewards offering varies by country but often includes 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.

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/