Quality and Regulatory Engineer

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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 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.

B. Technical Requirements

Be familiar with popular quality management standards

(i.e. : ISO13485;2016 and with 21 CFR  820).

C. Managerial Experience

D. Specific Duties

E. Language Skills

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