Excellent written and verbal communication skills; able to communicate effectively at all levels of the organization, and across all departments/functions.
Clinical experience in a hospital as a Rad Tech.
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.
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.
Preferred but not required knowledge of medical device regulations and standards applicable to EI 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
Bachelor’s degree or diploma in Engineering or Computer Engineering, Radiation Technology or related discipline.