Work Flexibility: Hybrid

We are currently seeking a Regulatory Affairs Specialist to join our Medical Division, Hybrid, to be based in Redmond, Washington.

What you will do

As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market and ensure ongoing compliance. In this role, you will:

Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfersIdentify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).Evaluate proposed products for regulatory classification and jurisdictionDetermine requirements and strategy for regulatory submission, approval pathways, and compliance activitiesPrepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products.Monitor the progress of the regulatory authority review process through appropriate communications with the agencyCommunicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication toolsMaintain current product registrations and assist to process registration changes when required.Perform timely reviews of collateral material for responsible product lines.Build relationships and interface with cross-functional teams (Engineering, International RA, Manufacturing, Marketing, etc.) to ensure accurate, complete, and timely submission preparation.Perform other duties as assigned by manager.

What you need

Bachelor’s degree in an Engineering, Science, or equivalent field0-2 years in a Regulatory Affairs rolePrevious experience with Class II/III medical devices

Preferred

Experience authoring regulatory submissions for product approvalExperience interacting with regulatory agenciesA passion for compliance and process driven style of workingExcellent communication skills, ability to influence others and clearly give and receive instructions and directionStrong organizational and analytical skills

Travel Percentage: 10%

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.