The primary role of the Post-Market Compliance and Safety Analyst is to coordinate compliance and safety related activities and the associated deliverables for IWC&S medical devices.Clinical experience as a Radiology Technician is necessary to be successful in this role.
- Engages cross-functional stakeholders in the Adverse Event Review Board (AERB) to collaboratively review and investigate customer complaints and adverse events reported to IWS, in order to meet regulatory obligations;
- Ensures that complaints and adverse events are investigated in a timely manner;
- Ensures that the results of investigations and determinations made by the AERB are accurately recorded;
- Ensures meeting minutes are recorded and action items are assigned/completed, as required;
- Provides subject-matter expertise to support the decision-making process.
- Collaborates with clinical subject-matter experts to evaluate health hazards associated with product malfunctions, as needed.
- Ensures all required records are complete and accurate, and have been reviewed/approved by appropriate stakeholders, including incident reports, recall reports, and recall status reports.
- Prepares, submits and manage applicable reports and documentation to regulatory agencies in applicable markets where IWC&S does business, in accordance with regulatory requirements.
- Prepares responses to queries from regulatory agencies on issues affecting IWC&S products.
- Escalates issues requiring additional input and oversight to Executive Director, Quality Assurance &
- Regulatory Affairs and IWC&S management representatives, as needed.
- Supports internal and external audits and inspections, as required by the business unit.
- Provides necessary support for establishing and implementing quality system procedures to ensure compliance with applicable medical device regulations and standards.
- Investigates quality problems, and performs corrective and preventive actions.
- Provides necessary support for, and coaches, business unit employees to ensure compliance with all applicable standards and regulations.
- Provides support for and input to ongoing improvement initiatives.
- Liaises with CHC Legal and Compliance teams, as required.
- Excellent written and verbal communication skills; able to communicate effectively at all levels of the organization, and across all departments/functions.
- Strong technical and operational problem-solving and trouble-shooting skills.
- Strong organizational and interpersonal skills.
- Must be proactive, collaborative, self-motivated, and a team player.
- Must have clinical experience as Radiology Technician
Minimum Requirements **
- Post-Market Compliance and Safety Analyst may act as the primary reference on a quality or regulatory issue, and is expected to provide recommendations and action plans that are technically correct and accurate. Recommendations and action plans may be reviewed for soundness of judgment and feasibility.
- Solid understanding of software behavior and able to understand product behavior from a user perspective. Experience in a software development industry preferred.
- Minimum 2 years experience in medical device company, or an ISO 13485/9001 regulated industry, or equivalent.
Additional Knowledge & Skills
Preferred but not required knowledge of medical device regulations and standards applicable to IWS products, including:
- ISO 13485:2016 Medical Device Quality System Requirements,
- ISO 14971:2007 / EN 14971:2012 Medical Device Risk Management,
- U.S. FDA Quality System Regulation (21 CFR 820), Medical Device Reporting (21 CFR 803), Corrections and Removals (21 CFR 806
- IEC 62304:2006 Medical Device Software Life Cycle Processes
- Medical Devices Regulations (SOR/98-282), COUNCIL DIRECTIVE 93/42/EEC
- Post secondary degree or diploma in Engineering or Computer Engineering or related discipline, or equivalent.
Job Type: Full-time