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Regulatory Affairs Specialist

4 weeks ago

Markham, Ontario, Canada Brunel Full time

Introduction

We are hiring a Regulatory Affairs Specialist for our client based in Markham, Ontario. The Regulatory Affairs Specialist will play a pivotal role in ensuring compliance for and overseeing the filing of regulatory submissions to Health Canada. Your responsibilities will include updating internal systems with regulatory information, preparing ASMF submissions, and coordinating communication with local and global stakeholders. This is a 5-month contract position that follows a hybrid work structure.

Responsibilities

  • Support/manage medical device regulatory change assessments and regulatory submissions to Health Canada, system updates, managing documentation and other duties.
  • Update required the company's internal systems and databases with regulatory affairs information, as per their SOP's.
  • Communicate and work with the company's local (eg, Canada brand team) and global stakeholders, according to their SOPs.
  • Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada.
  • Interact directly with Health Canada, and address questions on filed submissions to ensure approval.
  • Create detailed Yearly Biologic Product Reports (YBPR) by gathering data from the CPID, following regulatory guidelines and coordinating communication with key stakeholders.
  • Oversee and coordinate the submission of Public Release of Clinical Information (PRCI), ensuring clear communication with internal teams and Health Canada.
  • Clarifaxes etc.) efficiently and accurately in accordance with current Health Canada Guidelines and Corporate Guidance.
  • Maintain accurate records of regulatory documents and submissions by upload regulatory dossiers and supportive information into corporate internal database and platform.
  • Collaborate with regulatory affairs professionals, subject matter experts, and crossfunctional local and global teams to gather necessary documentation and information for regulatory submissions and pharmacovigilance related safety reports.
  • Participate in any ad-hoc or special regulatory projects as needed.

Requirements

  • 2+ years of experience in regulatory affairs, specifically with medical devices.
  • Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, chemistry).
  • Good understanding of the current Health Canada regulations and guidelines. Good team work and ability to work independently.
  • Strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.
  • Proficiency with Microsoft Excel and general computer skills.
  • Multi-tasking with attention to detail.

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.

About Us

Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.