The Senior Compliance Engineer is responsible for minimizing risk to the organization associated with pre and post production efforts under governing domestic and international requirements. This position ensures and helps maintain Compliance vigilance across the organization in compliance to applicable ISO, AAMI, EN, FDA, FCC, CSA type requirements and serves as the focal point for defining Compliance activities. This position helps define, interpret, and/or ensure the use of, and compliance to, appropriate test standards and regulatory requirements that apply to a medical device manufacturer.
Major, On-Going Responsibilities:
• Identify Compliance needs, such as requirements and testing standards to project teams, per product type, per desired country of sale.
• Collaborate with Product Development, Manufacturing, and Product Assurance to build requirements matrices per product type per country per appropriate regulations and to streamline product development efforts by designing and standardize testing protocols as appropriate.
• Lead process improvement efforts related to setting up internal company process related to compliance to required global standards and regulations.
• Lead business process optimization projects for reducing project cost and reducing time to market via standardization techniques.
• Participate in the review of design documentation to ensure that accepted engineering practices, laws and regulations have been met; obtain interpretations of requirements using international St. Jude affiliates as necessary
• Verify technical content in Design, Manufacturing, and Quality System sections of 510K, PMA, and IDE submission applications per appropriate guidelines and regulations within the scope of the submission strategies and plans.
• Provide project management for cross functional customers on compliance projects
• Remains current on present and pending international and domestic regulatory requirements and testing standards through St. Jude resources, training, external seminars, participating in standards committees and reading of technical articles.
Experience and Training:
• Master’s degree preferred. Minimum 5 years related work experience; e.g. as Product Designer / Product Development / Project Manager / Microbiologist / Sterilization Specialist / Engineer Regulatory Affairs / Quality Assurance / Quality Engineering.
• Minimum of 2 years experience in a medical device environment.
• Familiarity or experience with domestic and international medical device requirements (such as with the Medical Device Directives AIMD, MDD, CMDR, JGMP, ISO 13485:2003, ISO 14971, ASTM, Sterilization, Biocompatibility ISO 10993, etc.) is highly desired.
• Product safety experience and familiarity with EN, IEC, CSA type standards is desired
• Experience in designing and/or testing of electrical medical devices preferred