Ce site utilise des cookies. Pour en savoir plus sur notre politique d'utilisation des cookies, cliquez Politique d'utilisation des cookies

Regulatory Affairs Specialist - Hamilton - Stryker Corporation

Date de publication : 2/21/2019

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

Rejoindre notre réseau de talents

En rejoignant notre réseau de talents, vous optimisez votre recherche d’emploi et vos candidatures. Que vous décidiez de déposer votre candidature ou simplement d’enregistrer vos coordonnées, nous nous ferons un plaisir de rester en contact avec vous.

Rejoignez notre équipe