Quality and Regulatory Engineer

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We are excited to partner with AISpectral 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 AISpectral 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 wellrounded 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 biyearly) internal quality audits (as required by the business).
  
• Participate actively in companys 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 QARA Manager showing quality trends (improvement or deterioration) of the quality of the product.
  
• Participate to the preparation compilation and tracking of the yearly (or biyearly) customer surveys.

E. Language Skills

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

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