Regulatory Affairs Specialist

4 weeks ago

Mississauga, Ontario, Canada Abbott Full time

The Opportunity

This position is located in our Mississauga office, within the Core Lab division of Abbott. At Abbott, we're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Our diagnostics instruments run over 10 million tests daily, providing lab results for millions of people.

Key Responsibilities

  • Coordinate and prepare submissions for Core Lab product registration in compliance with applicable regulations.
  • Assist in responding to Health Canada's additional information requests and other requests.
  • Complete regulatory assessments for product changes.
  • Support Summary Report activities.
  • Ensure labeling, advertising, and promotional activities meet regulatory requirements.
  • Assist with impact assessments of emerging regulations.
  • Prepare and submit annual medical device license and establishment license renewals.
  • Support internal and external audits.
  • Maintain electronic Regulatory Affairs submission profiles and internal trackers.
  • Support product release processes and review/approve requests.
  • Review protocols and reports to support regulatory submissions and activities.
  • Support company initiatives as identified by management.
  • Comply with Canadian regulations, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications with employees, customers, contractors, and vendors.

Required Qualifications

  • Bachelor's degree required.
  • 1-3 years of experience in a similar role.
  • Experience with preparing and filing Class II-IV Canadian medical device license applications and working knowledge of the Canadian Medical Devices Regulations.
  • Knowledge of regulatory requirements for medical devices in Canada.
  • Knowledge of Canada's Food & Drugs Act.
  • Ability to work in a matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications

  • Post-graduate certificate in Regulatory Affairs.
  • RAPS certification.
  • Experience working in a broader enterprise/cross-division business unit model.

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