Regulatory Affairs Associate

4 weeks ago
Requisition ID
2017-3225
Job Location(s)
Stouffville ON Canada
Shift Type
First
Position Type
Full Time
Company
Cook Canada
Category
Regulatory Affairs

Overview

The primary purposes of this position are to support departmental activities by ensuring all products have appropriate Health Canada licenses and approval for sale; to support departmental activities by ensuring compliance with Health Canada regulations; to act as liaison between appropriate stake holders regarding regulatory matters and to support Quality Systems related activities.

 

Cook Medical is a family owned company with more than 10,000 employees.  For the past 50 years, we have been working with physicians to find simpler and safer ways to treat their patients.

What started with three simple products has grown into a global company serving 135 countries across the Americas, Europe, Asia, Africa and Australia.  Today, we build medical devices for more than 40 medical specialties.

Responsibilities

  • Support departmental activities by ensuring all products have appropriate Health Canada licenses and approval for sale.
  • Assist with Special Access Programme interactions.
  • Monitor new and existing part numbers to ensure that all products sold are licensed.
  • Ensure completion and submission of license amendments as required and determine applicable fees.
  • Assist with annual renewal process.
  • Prepare mandatory reports for RORB/MHPD.
  • Monitor Health Canada website for policy changes.
  • Ensure submissions comply with administrative policies.
  • Gather information from manufacturers and evaluate suitability for application.
  • Assist with product recalls
  • Communicate with Regulatory, Quality and associate personnel at other Cook Group companies.
  • Maintain Quality Systems Documentation.
  • Coordinate internal audit process.

Qualifications

  • Legally entitled to work in Canada
  • 2 years experience working with federal regulations respecting medical devices and quality systems.  Additional experience or specialized training in healthcare would be an asset
  • Appropriate clinical post-secondary education in a subject relating to nursing or medical/life sciences.
  • Must be confident, energetic positive, self-starter and results-driven.
  • Ability to form trusting and professional relationships throughout the organization and with Health Canada officials.
  • Highly effective communicator.
  • Able to travel outside of Canada

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