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Regulatory Affairs Specialist - Hamilton - Stryker Corporation

Date de publication : 5/21/2019

Résumé de l'offre

Description de l'offre

Individual Responsibilities:
 Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation
 Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance
Functional Responsibilities:
 Author submissions and other regulatory documents to obtain approval to bring new or modified products to market. (Class II, III and IV applications)
 Assess changes made to the device post launch to determine if the changes which are being made impact device license
 Utilize time management skills to effectively write, coordinate, and execute regulatory items
 Work with Marketing to develop annual product submission plans
 Advise on and coordinate the submission of the establishment license renewal as well as annual medical device license renewals
 Stay abreast of regulatory procedures, evolving regulations and guidelines and changes in the regulatory climate
 Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
 Investigate regulatory history of similar products to assess approval implications
 Attends to internal and external regulatory and licensing inquiries
 Communicate with all functional groups to ensure awareness of regulatory and quality requirements.
 Ensures scheduled submission dates are met and reports to management and marketing staff on regulatory product status and submission progress
 Coordinates special access program involving approvals, tracking, and final product release.
 Respond to RA information requests
 Assist in SOP development and review

 Monitor and maintain departmental metrics
 Completes other regulatory activities as assigned by manager

Conduct & Compliance
 Abide by and support the policies set forth in the Stryker Code of Conduct
 Understand that compliance with the Code of Conduct, as it may be amended by Stryker Corporation from time to time, is a condition of continued employment with Stryker
 Conduct work in compliance with all laws, rules, and regulations and in accordance with Stryker’s high ethical standards
 Report any violations of these policies and procedures to Stryker management or in the manner outlined in Stryker’s Ethics Hotline Policy

Work From Home: No

Travel Percentage: None

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