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quality assurance and regulatory specialist
58 minutes ago
QA/RA Specialist
Located in Calgary, AB, Canada, Kent Imaging Inc., is a leading innovator of medical technology that designs, manufactures, and markets imaging technology for limb preservation and surgical care. Kent holds multiple patents in oxygen imaging technology and continues to provide innovative and advanced diagnostic imaging solutions to aid healthcare systems nationally and internationally. Our focus at Kent is on how innovative medical technologies improve the health and well-being of patients.
We are seeking a highly skilled and detail-oriented Quality Assurance and Regulatory Specialist to join our team. The QA/RA Specialist is an experienced individual contributor responsible for supporting and executing Quality Assurance and Regulatory Affairs activities for medical devices throughout the product lifecycle. This role supports the maintenance and continuous improvement of the Quality Management System (QMS) and contributes to regulatory submissions, post-market activities, and international market expansion. The position works cross-functionally with Product Development, Operations, Clinical, and Commercial teams to ensure ongoing compliance with applicable regulatory requirements and international standards.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
QUALITY ASSURANCE
- Support and execute core QMS processes in compliance with ISO 13485, MDSAP, FDA 21 CFR Part 820, and other applicable regulations.
- Participate in and support Change Control, CAPA, Nonconformance, Complaint Handling, and Risk Management activities.
- Draft, review, and maintain controlled documents, including procedures, work instructions, forms, and quality records.
- Support internal audits, supplier audits, and regulatory inspections, including preparation of evidence and follow-up on corrective actions.
- Support supplier qualification, evaluation, and ongoing performance monitoring activities.
- Assist with validation activities (e.g., software validation, process validation) and review associated documentation
REGULATORY AFFAIRS
- Support regulatory submissions and lifecycle maintenance activities, including FDA 510(k), Health Canada MDL, EU MDR technical documentation, and other international registrations as required.
- Perform regulatory impact assessments for product, software, labelling, and process changes.
- Support post-market regulatory activities, including vigilance reporting, field actions, and regulatory correspondence.
- Maintain regulatory documentation, submission records, and registration trackers.
CROSS-FUNCTIONAL COLLABORATION
- Work closely with R&D, Manufacturing, Clinical, and Commercial teams to ensure regulatory and quality requirements are understood and implemented.
- Support design and development activities, including design reviews, design transfer, and technical documentation updates.
- Assist with training employees on QMS and regulatory requirements.
QUALIFICATIONS (EDUCATION, SKILLS, EXPERIENCE):
- Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field.
- Minimum of 3–5 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
- Hands-on experience working within an ISO 13485-certified Quality Management System.
- Experience supporting regulatory submissions and post-market activities for at least one major regulatory jurisdiction (FDA, Health Canada, EU MDR, or equivalent).
- Strong understanding of medical device regulations and quality system requirements.
- Proven ability to manage multiple priorities and work independently with minimal supervision.
- Excellent documentation skills with strong attention to detail.
- Strong written and verbal communication skills.
- Ability to work effectively in a cross-functional, fast-paced environment.
- Proficiency in Microsoft Office Suite; experience with eQMS tools is an asset.
Why work at kent?:
- Competitive salary & benefits
- HSA (Health Spending Account)
- An inclusive and diverse team of people
- Modern office space in Calgary's bustling Beltline area close to transit, shopping, restaurants, and parks
- Be part of our growth as we launch into international markets and build new technology
Job Type: Full-time
Pay: $70,000.00-$80,000.00 per year
Work Location: In person
