Regulatory Specialist and Quality Control Manager

Imaging Research & Technology (IR&T) develops and markets Ultra High-Quality PET scanners offering unmatched spatial resolution for the human brain as well as for a variety of preclinical scanner configurations. IR&T is proud to have strong partnerships and research collaborations with teams from the University of Sherbrooke, leading companies and various international research centers. Our LabPET scanners will enable major advances in the field of neurodegenerative diseases research and significantly increase diagnostic possibilities, changing how and when PET scanners are used by imaging centers. In addition to being involved with the production and improvement of our existing PET scanners, our ongoing R&D projects cover a wide range of technological innovations that will offer you the opportunity to be challenged and to surpass yourself.

Regulatory Specialist and Quality Control Manager

The Regulatory Specialist and Quality Control Manager is responsible for developing regulatory plans. He or She ensures regulatory compliance and optimization of quality system procedures relating to the regulatory requirements of IR&T. The Regulatory Specialist and Quality Control System interacts with governmental regulatory agencies and other third-party accrediting bodies. Medical Device Regulations are complex and constantly evolving. This person will work to help shape and enhance the quality culture in our company.

Main Job Responsibilities

  • Ensure that regulation-driven requirements are captured and addressed throughout product development and overview the internal quality control management;
  • Develop internal procedures, documents and tools required for ISO 13485 and by government regulatory agencies;
  • Prepare regulatory document for private labels and new homologations;
  • Ensure maintenance and proper retention of documents and records;
  • Be the go-to expert and quality leader, raising organizational awareness and understanding;
  • Instigate and implement effective corrective and preventative actions;
  • Define regulatory strategies and plan to optimize commercialization in Canada, in the US and internationally;
  • Assist in the conduct of clinical studies and the creation of a Research Ethics Board (REB) if needed;
  • Work with governmental regulatory agencies and other third-party accrediting bodies and will maintain approvals/licenses/authorizations for existing marketing;
  • Review marketing material to determine alignment with regulated product claims;
  • Compile and publishes all material required for submissions, license renewals and annual registrations;
  • Perform all other tasks related to regulation and quality control system.

Job Requirements

  • University Degree in engineering, law, science and/or a relevant field;
  • 2+ years of experience with ISO 13485, preferably for a medical device;
  • Proven ability to work independently to meet rigorous deadlines without a rigidly defined process in place;
  • Process oriented, logical, analytical, meticulous, and highly organized;
  • Effective oral and written communications skills in English and in French;
  • Excellent project management skills with a strong ability to prioritize tasks;
  • Strong knowledge of federal regulations;
  • Interest in continuous learning about regulatory aspects.

Salary and Conditions

  • Competitive salary, according to experience;
  • One-year contract with possibility of full-time and permanent position.

Given the current environment and the nature of the tasks that may not require a physical presence, it is possible that the first few months of the position could be done remotely.

Interested candidates are invited to send their curriculum vitae by email to admin@imagingrt.com