Regulatory Affairs Specialist - 30733BR - EN in Hamilton at Stryker Corporation

Date Posted: 5/16/2018

Job Snapshot

Job Description

Job Overview
This position is responsible for ensuring compliance with Health Canada regulations for the commercialization of medical devices. This individual must serve as a contributing member of the Regulatory Affairs team while championing Stryker’s Mission and Values.

Responsibilities
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

Knowledge & Skill Requirements
  • Working knowledge of medical device regulations
  • Strong computer skills (Excel, Word, Power Point, Share point)
  • High standard of integrity and ability to meet deadlines
  • Highly organized and able to prioritize tasks
  • Project management and report writing; preferable
  • Strong oral and written communication skills with both internal and external contacts
  • Ability to make and support decisions with regards to regulatory and quality issues

Job Requirements

  • University Degree required
  • Post-graduate diploma in Regulatory Affairs or Quality Assurance
  • Minimum of two years’ experience in a regulatory affairs and quality assurance environment
Internal applicants with an equivalent combination of education, experience and performance over time at Stryker will be considered

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