Quality and Regulatory Associate
Status: Full time (combination of remote and at location)
Rehabtronics is a rapidly growing medical device company with operations in Edmonton, AB and Vancouver BC. We are on a mission to develop technologies that improve the lives of people with paralysis. Our products have helped thousands of people around the world.
We are looking for an experienced quality project associate to help maintain and support our operations.
- Act as core team member of QARA for project development life cycle.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Maintain establishment licenses, renewals and annual registrations
- Provide responses to regulatory agencies regarding product information or issues.
- Assist with preparation and submissions of regulatory agency applications
- Provide quality guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Investigate product complaints and assess reporting to appropriate regulatory agencies, as necessary.
- Develop and maintain standard operating procedures as required.
- Release product batch documents per procedure as required.
- Train staff in regulatory policies or procedures.
- Participate in activities such as audits, regulatory agency inspections, or product recalls.
- Support new and on-going manufacturing efforts including final inspection, test of components and assemblies, and disposition of discrepant materials.
- Assist with resolution of product and process defects as determined through failure analysis, focusing on root cause analysis and implementation of effective corrective action.
- Updates senior management with quality & compliance issues & through Management reviews on regular basis.
Your education, skills and experience
- Bachelor’s degree in Sciences would be an asset
- A minimum of 3+ years of experience in the development, implementation, and maintenance of a quality management system, preferably in the context of medical device.
- Broad knowledge of medical device regulations (e. g. QSR, ISO 13485, MDSAP, etc)
- Experience with Establishment licenses, Registrations and other Product submissions preferred
- Details oriented individual.
- Ability to travel, as necessary.
If this position interests you, please send your resume with a cover letter to firstname.lastname@example.org