Post Market Regulatory Surveillance Specialist (Hybrid)

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

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com

We are currently seeking a Post Market Surveillance Specialist to join our Stryker Emergency Care Division based in Redmond, WA in a hybrid work environment.

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.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

What you will do

As the Post Market Surveillance Specialist, you will support and directly impact the safety and effectiveness of Stryker's Emergency Care portfolio.

• Preparation and submission of post-market reports and submissions (MDRs and MIRs)
• Maintain systems to trigger and log regulatory reporting.
• Track and maintain files on annual licenses, registrations, and listings.
• Maintain systems to track, manage, and report product-associated events.
• Track product complaints, events, and recalls.
• Identify information sources and resources for local, regional, and global regulations.
• Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information.
• Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.).
• Provide information used to evaluate proposed products for regulatory classification and jurisdiction.
• Research requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities.
• Assist in the development of regulatory procedures and SOPs.

What you need

• Bachelors Degree required.
• 2+ years' professional experience.
• 2+ years medical device preferred.
• Strong time management, writing, coordination, and execution skills.
• Excellent analytical and writing skills.
• Excellent interpersonal, written and oral communication skills.
• Effective organizational skills.
• Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

About Stryker

Our benefits:

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.

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 on our referral page

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.