Overview

Medical Device Quality and Regulatory Specialist Jobs in Vaughan, Ontario, Canada at Propulsion Recruitment

Our client, a company specializing in the distribution and servicing of medical devices, is currently seeking a

Quality Assurance

and Regulatory Affairs Specialist to join their team.

Full time. Permanent.

Responsibilities:

Manage document control processes: preparation, review, distribution, training, filing, and archiving;

Support internal/external audits and related follow-ups;

Assist in investigations and root cause analyses of non-conformities;

Contribute to corrective/preventive actions and

continuous improvement

efforts;

Help maintain regulatory documentation and support application renewals;

Collaborate with teams on quality/regulatory matters and process improvements;

Assist with post-market surveillance, including tracking recalls, customer feedback, and complaints;

Support supplier qualification and licensing renewals;

Contribute to health and safety initiatives;

Perform other QA/RA duties as assigned.

Profile:

Strong

communication

and

teamwork

skills;

Ability to handle regulatory/quality concerns with

professionalism

; 1+ year in QA/RA;

Bachelor’s in Health Sciences, Engineering, Pharmaceutical or any other related field;

Familiarity with ISO 9001, ISO 13485, MDSAP, FDA CFR 820, or SOR 98-282 is an asset;

Strong organizational skills;  capable of managing multiple priorities;

Proficient in Microsoft Office.

Benefits:

Comprehensive benefits package

after 3 months;

Access to a wide range of employee programs and resources; 3 weeks vacation to start.

Title: Medical Device Quality and Regulatory Specialist

Company: Propulsion Recruitment

Location: Vaughan, Ontario, Canada

Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)

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