Regulatory Affairs Specialist – Core Lab

3 weeks ago

Mississauga, Ontario, Canada Abbott Full time

The Opportunity

This position is located in our Mississauga office within the Core Lab division at Abbott, where we empower 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 required for registration of Core Lab products and distributed products in compliance with applicable regulations.
  • Assist in responding to additional information requests and/or other requests received from Health Canada.
  • Complete regulatory assessments for product changes.
  • Support the Summary Report activities.
  • Ensure that labeling, advertising, and promotional activities meet applicable regulatory requirements.
  • Assist with impact assessments of emerging regulations.
  • Prepare and submit annual medical device license and establishment license renewals by the due date prescribed by Health Canada.
  • Support internal and external audits.
  • Maintain electronic Regulatory Affairs submission profiles and internal trackers.
  • Support the product release process or reviewing and approving requests for product release.
  • Review protocols and reports to support regulatory submissions and activities.
  • Support all Company initiatives as identified by management.
  • Comply with Canadian regulations, company policies, operating procedures, processes, and task assignments.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Perform other related duties and responsibilities as assigned.

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, Investigational Testing 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 highly 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 the 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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