Stryker
Medical Devices & Equipment
See how your profile stacks up against this role.
We compared the job requirements to your profile to show where you're strong and where you fall short.
We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular division. This position is based remotely anywhere in the United States.
As the Staff Regulatory Affairs Specialist, you will support Stryker’s neurovascular devices. You will work to bring new medical devices to the market while ensuring ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, and interact with regulatory agencies/notified bodies in major markets including the US, EU, Canada, Japan, China, Australia, Brazil, and more.
What you will do
What you need
Required
Bachelor’s Degree (B.S. or B.A.)
Minimum 4 years of experience in an FDA-regulated industry
Minimum 2 years of experience in regulatory affairs
Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)
Preferred
Bachelor’s degree in engineering, science, or related field
Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline
Experience with Class II or Class III medical devices
Experience authoring 510(k) submissions or equivalent regulatory filings
Experience interacting with regulatory agencies or supporting regulatory meetings
United States of America Pay Ranges:
Travel Percentage: 20%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.
After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.
Marcus Rivera
Chief Revenue Officer
VoxelCloud
US Tech Solutions
PROCEPT BioRobotics
Henry Schein
Erasca, Inc.
Stryker
Stryker
Stryker
