Staff Regulatory Affairs Specialist (Contract) in Hamilton at Stryker Corporation

Date Posted: 9/5/2018

Job Snapshot

Job Description

Individual Responsibilities:
• Proactively collaborates with internal teams/departments to promote a culture of inclusiveness and cooperation  • Coach, guide, and advise RA team members  • Responsible to live and exemplify Stryker’s Values: Integrity, Accountability, People, and Performance 
Functional Responsibilities:
• Responsible for overseeing all regulatory submissions, product technical files and devices licensing activities • Maintains updated knowledge of current regulations and identifies special requirements, that may exist based on product types, or current regulatory conditions and communicates these to appropriate personnel • Strategically expedite the registration of new products. support commercial activities while ensuring regulatory compliance • Plan, co-ordinate and chair pre-submission, registration and post-market meetings with Health Canada, including the preparation of briefing materials, and meeting minutes to Health Canada • Represent Canada on international Regulatory teams to best ensure that the Canadian requirements are reflected in international and corporate projects • 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 • 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  • Advise on and coordinate the submission of the establishment license renewal as well as annual medical device license renewals • Attend to internal and external regulatory meetings, including Medec • Communicate with all functional groups to ensure awareness of regulatory and quality requirements.  • Oversee the special access program involving approvals, tracking, and final product release • Assist in SOP development and review  • Monitor and maintain departmental metrics  • Complete 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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