Specialist, Regulatory Affairs
ICU Medical, Inc
CA-CA-St. Laurent
24d ago

Position Summary

Primary responsibilities of the Regulatory Affairs Associate include preparing regulatory filings for products in portfolio to secure timely approvals and ensure ongoing compliance to Canadian Regulations, management of post-

approval changes and Regulatory Affairs support.

Essential Duties & Responsibilities

Reporting to the Canadian Regulatory Lead, the Regulatory Affairs Associate is responsible for the preparation of regulatory filings to Health Canada for products in the portfolio (DINA, NCs, S / NDS, NDS, Annual DIN Renewals, Annual Device License Renewals, Medical Device License Applications, and Medical Device License Amendments-

  • including fax-backs). The Regulatory Affairs Associate is also responsible to liaise with relevant stakeholders to ensure timely submissions and approvals;
  • Responsible to maintain ICU Medical’s Regulatory databases

  • As assigned, assesses post-approval changes, and recommends regulatory actions needed to support changes in Canada;
  • Ensures compliance of assigned dossiers;
  • Reviews labeling, training, Non-training and Promotional Materials, as assigned, to ensure compliance to local Regulatory requirements;
  • Effectively contributes to and executes regulatory strategies in line with business needs;
  • Assists in the development and maintenance of departmental processes, databases, SOPs and associated documents.

    Assists in continuous improvement projects

    Work on special projects as they arise

    Knowledge, Skills & Qualifications

  • Excellent interpersonal skills and the ability to work in a team environment
  • Strong organizational skills and a high level of attention to detail
  • Excellent French & English written and oral communication skills is a requirement

  • Ability to prioritize key business objectives and respond quickly to changing priorities
  • Able to multitask and work in a fast-paced environment
  • Proficient in Excel, Word and Outlook; able to work in a variety of databases and create reports and analyses
  • Education and Experience

  • Bachelor’s degree from an accredited college or university
  • Minimum 3 years of regulatory and medical device experience
  • Must have working knowledge of applicable regulatory requirements
  • Basic experience in regulated manufacturing
  • Travel Requirements

    Typically requires travel less than 5% of the time

    Physical Requirements and Work Environment

  • While performing the duties of this job, the employee is regularly required to talk or hear. This is largely a sedentary role;
  • however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

    This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

    CECI EST UN MANDAT TEMPORAIRE

    Habilité à établir les priorités pour ce qui est des objectifs clés de l’entreprise et capacité à s’adapter rapidement aux changements de priorités

  • en vigueur
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