Stryker Senior Regulatory Affairs Specialist in Minnesota
Who we want
Focus. Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.
Communicators. Articulates well and expresses ideas effectively.
Learners . Great desire to learn and looks to continuously improve.
Teammates . Supports, encourages, and inspires others.
What you will do
The Senior Regulatory Affairs Specialist develops strategies for worldwide governmental approvals to introduce new, modified and mature products to the market by preparing worldwide regulatory. They participate on cross functional teams to develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies and review labeling and marketing material during the pre-market phases. The Regulatory Affairs team also evaluates proposed design changes for both new products and sustaining products. They support the product life cycle by assessing changes made to the device post launch to determine the regulatory impact to the current clearance/approval by all regulatory bodies.
•Support the Manager of Regulatory in developing a partnership with other departments in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.•Exposure to all types of medical device products with an array of clinical applications.•Partner regularly with the engineers on the team compiling regulatory submissions.•Provide strategic direction on how to best streamline our process and use more of a risk-based approach to making decisions.•Awareness of world wide regulatory requirements and systems.•Prepare US and OUS regulatory submissions required for approval or registrations, including 510(k)s, Memos to 510(k) files, Technical Files, Design Dossier, and other regulatory submissions as applicable.•Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.•Proficient in timely review of technical data.•Assist in the review of documentation, protocols and reports received; and prepares additional written materials as needed.•Additional computer skills: Adobe Acrobat and document processing/Microsoft Word.
What you need
•Bachelor’s degree preferred in life science, engineering discipline or similar field •3 - 5 years’ experience in regulatory areas.•Excellent understanding of FDA Regulations, International ISO Standards, European Medical Device Directive (MDD), Canadian Medical Device Regulations and other OUS regulations
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