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.
