Regulatory Affairs Specialist

Overview

This is an excellent opportunity to join a fast-growing, well-established medical device industry leader as a Regulatory Affairs Specialist. This position is currently a 6-month contract with the possibility of extension and/or full-time employment in the future.

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 ensure compliance with Health Canada regulations; to act as liaison between appropriate stakeholders regarding regulatory matters; and to support Quality Systems related activities.

Cook Medical is a privately held, Indiana-headquartered company with a global reach. Our roots are in minimally invasive medical devices, and we are always expanding into new areas of treatment - cellular therapies, biologics, regenerative therapies, and more. We have developed businesses that support the communities where we live and work, such as hospitality, transportation, and real estate.

Our work environment focuses on bringing people together, fostering relationships that promote respect, inclusion, diversity, and equality in all of our interactions. These collaborative working relationships foster innovation and make Cook, our employees, and our communities stronger.

Cook is committed to providing accommodations for people with disabilities. If you require accommodation, we will work with you to meet your needs.

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 the annual renewal process.
• Prepare mandatory reports for ROEB.
• 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 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.