Regulatory Affairs Professional

6 days ago

Markham, Ontario, Canada Brunel Full time

Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to join our team based in Markham, Ontario. This individual will play a pivotal role in ensuring compliance for and overseeing the filing of regulatory submissions to Health Canada.

The successful candidate will have 2+ years of experience in regulatory affairs, specifically with medical devices, and a Bachelor's degree in a relevant field (e.g., life sciences, pharmacy, chemistry).

Key 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 (e.g., 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.
  • 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 cross-functional local and global teams to gather necessary documentation and information for regulatory submissions and pharmacovigilance-related safety reports.

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.
  • Strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.
  • Proficiency with Microsoft Excel and general computer skills.

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