Education Requirement This position requires a Bachelor of Science degree, or foreign equivalent, in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.br br Work Experience Requirement 10 years Quality Systems andor Regulatory experience in the medical device industry or another related field that is federally andor internationally regulated.br br Alternatively, the employer will accept Associates with 15 years of experience in the medical device industry or other related field that is federally andor internationally regulated.br br Specific Skills Requirement Additionally, the applicant must have professional experience with 1 Working knowledge of international medical device standards and regulations e.g., ISO 13485, ISO 10993x, IEC 60601x, U.S FDA 21 CFR 820, MDSAP, EU MDR, etc.; 2 Interprets and assesses regulatory requirements for applicability to applicable products and quality system processes andor liaise with external regulatory resourcesservices; 3 Communicates with international regulatory entities and customers regarding licensing inquiries, product registrations, import export regulations; 4 Supporting external audits and regulatory inspections; 5 Supporting new product development teams by establishing product regulatory strategy for applicable markets; 6 Applies a riskbased approach in providing options and regulatory recommendations for engineering changes throughout the product lifecycle; 7 Preparing initial product registrations and submissions, device listings, and applicable renewals when required; 8 Reviewing and approves product labeling and product literature for compliance with applicable international standards and regulations; 9 Maintains documentation needed to support regulated product throughout the products lifecycle, including but not limited to, technical file maintenance, recall coordination and medical device reporting; 10 Supports creation and maintenance of technical documentation and Declarations of Conformity in support of international product registrations e.g., CE marking of conformity; 11 Establishes and manages corrective and preventive actions CAPA systems and processes, acts as CAPA Review Board Chair CRB, clinical evaluations and literature searches; 12 Implements corrective and preventive actions, and corrections, as necessary to address nonconformities and prevent their recurrence. Mentors less experienced staff on the appropriate CAPA methodologies; 13 Manages the internal audit program, as required, to determine QMS effectiveness and to ensure compliance with the established regulatory requirements. Acts as lead internal auditor; 14 Participates in Quality Planning; leads Quality Planning meetings; and 15 Supports preparation for and participate in Clinical Evaluations, Management Reviews, External Audits and other duties as assigned.
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