Job Description

Regulatory Affairs Associate
Department: Quality Assurance The Regulatory Affairs Associate works to register and maintain registrations of products worldwide with primary emphasis on liaising with regulatory agencies and third parties on all regulatory matters concerned with product development and registrations.
Main Duties & Responsibilities:

• Prepares regulatory applications (either for Health Canada or for international regulatory agencies) to achieve organizational objectives;
• Prepares, updates and maintains regulatory documentation as appropriate for product classification;
• Responsible for preparing submission dossiers, safety reports, etc. for submission to the Regulatory Authorities in support of market clearance and product registrations;
• Maintains product registrations;
• Coordinates and organizes documentation for submission regarding Adverse Event reports to regulatory agencies;
• Provides documented regulatory assessments to support new product development;
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations;
• Acts as a regulatory representative on product development teams, communicates regulatory requirements and impact of regulations to the development team;
• Advises on changes to regulations, standards and legal stipulations, and participates in updates to quality system documentation to reflect such changes;
• Conducts/participates in audits of the quality system to ensure compliance with regulatory requirements;
• Keeps abreast of domestic and global regulatory trends, laws and movements utilizing regulatory intelligence tools;
• Maintains positive and cooperative communications and collaboration with all internal and external stakeholders;
• Supports Marketing and Sales by participating on Business Teams to provide RA advice and information, as required;
• Maintains positive and cooperative communications and collaboration with all internal and external stakeholders;
• Supports Marketing and Sales by participating on Business Teams to provide RA advice and information, as required;
• Other duties as required.

• Minimum Bachelor of Science and a minimum of 2 years of Regulatory Affairs experience in the Medical devices or Pharmaceutical Industry;
• Regulatory affairs certificate or post-graduate diploma in Regulatory Affairs is desired;
• Knowledge of ISO 13485:2016 MDSAP, CMDR, European MDD/MDR, US FDA QSR;

• Excellent communication skills (French & English) in reading, writing, and speaking at all levels of organization;
• Flexible and demonstrated ability to adapt to change.
• Ability to work independently as well as part of a team.
• The ability to manage multiple competing priorities;
• Self-starter that is highly motivated, creative, and able to work in a team environment.