Compliance Analyst supporting AML, responsible gaming, audits, and regulatory reporting for Pala Interactive's gaming platform. Coordinating compliance across North American jurisdictions and gaming regulators.
About the role
- Regulatory Affairs Specialist managing medical-device submissions, documentation, and audits for Canadian HA filler manufacturer Prollenium. Supporting Health Canada, FDA, EU, and quality-regulatory requirements.
Responsibilities
- Manage regulatory affairs projects, applications, and submissions for Class I–III medical devices and support mandates involving cosmetic products
- Prepare, review, and maintain technical and regulatory documentation for medical devices and equipment
- Maintain technical files, device/equipment specifications, drawings, test reports, risk documentation, labelling, and Instructions for Use (IFUs)
- Review equipment and product changes for regulatory impact and required documentation
- Support equipment qualification, verification, validation, and performance-testing documentation
- Support regulatory submissions, registrations, licenses, amendments, and renewals for Health Canada, US FDA, EU, and other applicable authorities
- Coordinate regulatory documentation from equipment manufacturers, suppliers, and contract manufacturers
- Support change controls, deviations, CAPAs, and non-conformances with regulatory impact
- Assist with Technical Files, Design Dossiers, PMCF documentation, PSURs, and other regulatory records
- Support regulatory audits and inspections and ensure requested documentation is accurate and readily available
- Prepare and support ARTG applications
- Support external audit preparation, including Microbiology, MDSAP, FDA, and CE audits
- Provide regulatory inputs for Management Review
- Support quality, microbiology, and other applicable audits and resolution of non-conformances
- Report to the Chief Regulatory, Clinical and Medical Affairs Officer
- Work cross-functionally to ensure medical devices, equipment, and associated documentation meet regulatory requirements and timelines
Requirements
- Bachelor’s degree in Biomedical Engineering, Life Sciences, or a related discipline
- Minimum 2–4 years of Regulatory Affairs experience within the medical device industry; medical device experience is essential
- Experience preparing and maintaining technical and regulatory documentation for medical devices and/or equipment
- Working knowledge of Health Canada, US FDA and EU medical device requirements
- Experience with technical files, equipment documentation, specifications, validation/testing documentation, risk documentation, labelling, and IFUs
- Strong attention to detail, technical writing, organization, and ability to manage multiple priorities
- Experience supporting Class II and/or Class III medical devices and medical device equipment
- Knowledge of ISO 13485, FDA Quality System requirements, equipment qualification/validation, and change control
- Experience supporting FDA, Health Canada, MDSAP, CE/EU audits or regulatory submissions
- Ability to work cross-functionally in a regulated environment
- Ability to manage different projects in parallel
- Team player within the Regulatory Team and other functions and departments
Benefits
- Competitive compensation
- Benefits
- Development opportunities
- Hybrid work model with 1 day working from home
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