Stryker Senior Regulatory Affairs Specialist in Minnesota
Support the Manager of Regulatory in developing a partnership with other departments in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.
Participate in and support product development teams for new & continuing projects.
Assist in the review of documentation, protocols and reports received; and prepares additional written materials as needed.
Prepare US and OUS regulatory submissions required for approval or registrations, including 510(k)s, IDEs, PMAs, Memos to 510(k) files, Technical Files, Design Dossier, Medical Device Reports, and other regulatory submissions as applicable.
Prepare responses to FDA letters, supplements, and amendments.
Review and approve product & process changes and labeling materials according to regulations.
Write Standard Operating Procedures (SOPs) as needed to comply with the regulations.
Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.
Work From Home: No
Travel Percentage: None
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.
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 Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com