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Status: Regular, Full Time

Position Overview:

The Manager Regulatory Affairs ensures ADD Canada is in compliance with the Canadian Medical Devices Regulations.

The Manager Regulatory Affairs, actively contribute to the development and implementation of regulatory strategy for assigned projects, this includes the ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/externalauthoring/review/comment adjudication and finalization (submission and archival).

He/She acts as a liaison between Regulatory and other functional areas, representing the department in cross-functional team meetings, internally and externally. In collaboration with Marketing / Sales management, he/she provides regulatory support for all product-specific activities related to gaining and maintaining market approval.

The Manager Regulatory Affairs manages budget and costs of all the activities which he/she is accountable for. Also reports periodically on the performance of the department (budgets Vs actual targets).

Responsibilities:

Daily

• 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.
• Support and maintain internal and external distribution mechanism for Customer Communications.
• PAR Manual
• Ensure that labeling, advertising and promotional activities meet applicable regulatory requirements.

Monthly

• Report required metrics to Division.
• Keep current on quality trends, Abbott Division quality initiatives and regulatory changes.
• Oversee Investigation Testing (clinical trials) for new products when necessary.
• Maintain electronic Regulatory Affairs Submission Profile

Every Year

• Review annual employee training plans and modify as appropriate.
• 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, provincial authorities) to maintain or establish a good rapport and business relationship.

Required Education and Experience:

• Bachelor’s Degree in Science
• 5 to 8 years of experience in a related field

Required Skills and Abilities:

• Bilingual (French and English) is an asset;
• Auditing experience is an asset;
• 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 communication skills;
• Strong organizational skills with a proven ability to drive for results;
• Project Management and/or Supervisory experience is an asset;
• Ability to take key actions and demonstrate behavioral anchors the support all Abbott leadership competencies.

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