Post Market Regulatory Surveillance Specialist (Hybrid) - Washington, Redmond 11811 Willows Rd Ne

Work Flexibility: Hybrid or Onsite

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.

Travel Percentage: 0%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.