Regulatory Affairs Specialist – Core Lab (Mississauga)

at  Abbott Laboratories

About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity
This position work from our Mississauga office in the Core Lab division. At Abbott – Core Lab, we’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

What You’ll Do

• Coordinate and prepare submission required for registration for 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 assessment 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 due date prescribed by Health Canada;
• Support internal and external audits;
• Maintain electronic Regulatory Affairs submission profile and internal trackers;
• Support the product release process or reviewing and approving requests for product release;
• Review protocols and report 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, on occasion, 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 ability to effectively communicate at multiple levels in the organization;
• Multitasks, prioritizes and meets deadlines in 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.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

• Coordinate and prepare submission required for registration for 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 assessment 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 due date prescribed by Health Canada;
• Support internal and external audits;
• Maintain electronic Regulatory Affairs submission profile and internal trackers;
• Support the product release process or reviewing and approving requests for product release;
• Review protocols and report 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, on occasion, as assigned