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We are excited to partner with AI-Spectral Technology Corp. in their search for a Quality and Regulatory Engineer.

Purpose and Scope

The Quality and Regulatory Engineer at our organization will be responsible for the development, implementation and administration of procedures and processes that ensure compliance with all regulatory requirements.
These include requirements for product development, R&D environment, quality assurance and control, and regulatory compliance of products and services sold in different geographical areas.

Responsibilities

• Under the responsibility and guidance of the Manager Quality and Regulatory, execute the regulatory tasks for AI-Spectral Technology Corporation to ensure compliance with applicable regulatory requirements.
• In compliance with AIS’ QMS (Quality Management System), prepare, update and release the documents needed to ensure that the QMS system and its major components (i.e.: QMM, Standard Operating Procedures and Internal Controlled Documents) are consistent with applicable international regulatory requirements for developing, manufacturing and servicing AIS’ medical devices.
• Support the Manager Quality and Regulatory in resolving and addressing any issues or questions of a regulatory nature.
• Stay up to date with evolving regulatory trends relevant to AIS’ medical products and services.

Organizational relationships

The Quality and Regulatory Engineer Affairs reports directly to the Manager - Quality & Regulatory.

JOB REQUIREMENTS

A. Education and Training

• The Quality and Regulatory Engineer should have a third level education, preferably in a field that offers an opportunity to gain a well-rounded background.
• The Quality and Regulatory Engineer should be well versed and have significant experience in the medical devices regulatory field.
  Having specific experience with Class II ophthalmic medical devices would be an asset.
• Being current with regulatory requirements in North America is also an important asset.

B. Technical Requirements

• Good working knowledge of popular MS Office programs generally, and specifically in MS Word, MS Excel and MS PowerPoint. A working knowledge of JIRA would be an asset.
• Be familiar with MDSAP (Medical Devices Single Audit Program).
• Be familiar with popular quality management standards (i.e.: ISO13485;2016 and with 21 CFR  820).

C. Managerial Experience

• Previous experience in a leadership role in a technical or managerial function.
• Good communication and training skills. The incumbent must be able to provide training to staff on Quality and Regulatory matters.

D. Specific Duties

• Provides regulatory support for AIS Technology medical products, including identification of relevant regulatory requirements and works with others to ensure these are met.
  
• Support the regulatory process for FDA & Health Canada.
  
• Assist in the preparation of regulatory submission documentation.
  
• Engage with regulatory authorities through authorized representatives, agents and the regulatory consultants (as required).
  
• Assist in the preparation and execution of yearly (or bi-yearly) internal quality audits (as required by the business).
  
• Participate actively in company’s external audits and assist the Management team in addressing any issues identified during the audits (as required).
  
• Provides regulatory guidance, training and support to management and staff.
  
• Contributes regulatory inputs to Management Team meetings.
  
• Manage the CAPA (corrective action / Preventive Action) database and work closely with external material or service suppliers.
  
• Design and implement an action plan to rectify any issue identified in the CAPA database.
• Provide data / monthly matrix to the QA-RA Manager showing quality trends (improvement or deterioration) of the quality of the product.
  
• Participate to the preparation, compilation and tracking of the yearly (or bi-yearly) customer surveys.

E. Language Skills

• Fluent in English is essential.
  
• Knowledge of French would be an asset.

Work in Ottawa utilizes a secure, closed AI environment for the initial screening of resumes, ensuring your data remains safe while helping us efficiently identify top candidates. We encourage all applicants to apply, even if you do not meet every requirement if you possess relevant skills, enthusiasm and eagerness to grow, we want to hear from you! To enhance your visibility, consider including relevant keywords in your resume.

If you require any accommodation during the hiring process, please reach out to the hiring team.