Abbott Manager Regulatory Affairs - Abbott Diagnostics (Mississauga) in Mississauga, Ontario
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Status: Regular, Full Time
The Regulatory Affairs Manager ensures compliance with Health Canada Medical Device. He/She ensures ADD Canada is in compliance with the Canadian Medical Devices Regulations. He/She ensures that regulatory strategies are defined and efficiently implemented, and that strategies are maintained in line with changing regulatory and business needs. In collaboration with Marketing / Sales management, he/she provides regulatory support for all product-specific activities related to gaining and maintaining market approval.
Coordinate, source, reformat, and prepare submission documentation required for registration dossiers to license all ADD products and distributed products in compliance with new Health Canada Medical Device Regulations.
Respond to Health Canada requests for additional information required for license submissions.
Complete and file mandatory problem reporting to Health Canada and requests for additional information.
Maintain electronic Customer Communications tracking for all Field Actions (Recalls) and Product Information.
Support and maintain internal and external distribution mechanism for Customer Communications.
File Field Actions (Recalls) with Health Canada to comply with Section 64 and 65 of the Medical Device Regulations.
Ensure that labeling, advertising and promotional activities meet applicable regulatory requirements.
Report required metrics to Division.
Oversee Investigation Testing (clinical trials) for new products when necessary.
Maintain electronic Regulatory Affairs Submission Profile.
Establish annual regulatory goals for the site and monitor to completion.
Prepare annual device and establishment license renewals.
Annual renewal; register all devices and changes by due date prescribed by Health Canada.
Attend trade related expositions and conferences for up-to-date information on all current developments affecting Regulatory requirements.
Meet with regulatory agency representatives (Health Canada, CFIA, etc.) to maintain or establish a good rapport and business relationship.
Required Skills & Abilities:
Demonstrated initiative and ability to work both independently and as a team member;
Considerable knowledge of the pertinent regulations affecting IVDD’s (ie: QSR, Labeling, International Standards and Directives);
Solid analytical, problem solving and public relations skills;
Excellent English communication skills;
Strong organizational skills with a proven ability to drive for results;
Project Management and/or Supervisory experience is an asset;
Intermediate skills in MS Office (Word, Excel, Powerpoint);
Must be able to travel approximately 10% of the time;
Ability to take key actions and demonstrate behavioral anchors the support all Abbott leadership competencies.
Required Education and Experience:
Bachelor of Science is required.
5-8 years of experience in a similar role, preferably within medical device/diagnostics industry.
Experience working in a broader enterprise/cross-division business unit model preferred.
Experience working with Health Canada.
Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.
Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.
We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.
Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com