Consultant ISO 13485

Project overview

For our client, a company in the medical industry, we are looking for a Consultant ISO 13485.

Responsibilities

• The services include the technical analysis, support, and assistance for the "South Africa Process Compliance" project, as well as the evaluation and optimization of related processes and contract structures, taking into account the applicable regulatory requirements for medical devices.
• Relevant regulatory requirements include, in particular, the "Medicines and Related Substances Act 101" and the "Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices No. 1515".
• The project scope also includes two products that are currently classified exclusively as medicinal products in South Africa. Since these products are classified as medical devices in other markets, the associated processes, documentation, and contract structures are also subject to analysis. The goal is to ensure consistent regulatory assessment and compliant design of processes and contractual relationships within the supply chain.
• Scope of Services
• Project support and technical coordination
• Technical coordination of project-related issues among the involved stakeholders
• Promotion of transparent information exchange in the project environment
• Preparation and presentation of project-related status information to the Project Owner
• Technical support for work packages defined in the project and assistance with their content coordination
• Gap analysis of processes and contracts
• Analysis of existing processes and interfaces between the involved stakeholders
• Creation of a structured representation of product, information, and responsibility flows within the supply chain
• Review and analysis of existing contractual relationships between the involved stakeholders
• Comparison of existing contracts with current processes to identify redundant, outdated, or missing contract content
• Comparison of processes and contracts with applicable regulatory requirements for medical devices to identify areas for adjustment
• Development of a structured gap list with identified fields of action and proposals for necessary process and contract adjustments
• Conception of regulatory compliant processes
• Technical advice to the responsible departments in the conception and design of regulatory compliant processes
• Development of concepts and proposals for new processes and necessary process adjustments
• Presentation and technical coordination of process proposals with the involved stakeholders
• Technical evaluation of processes regarding regulatory requirements using own expertise and/or involving relevant quality assurance functions
• Technical review of developed processes regarding completeness, practicality, and regulatory compliance
• Support for the involved stakeholders through technical advice and transparency creation in connection with required approval processes
• Conception of regulatory compliant contracts
• Technical advice to the responsible departments in the conception and design of regulatory compliant contract structures
• Development of concepts and proposals for new contracts and necessary contract adjustments
• Presentation and technical coordination of contract proposals with the involved stakeholders
• Technical advice to the responsible departments in the preparation and technical evaluation of contract negotiations
• Technical evaluation of contracts regarding regulatory requirements using own expertise and/or involving relevant quality assurance functions
• Technical review of contract drafts regarding completeness, consistency, and regulatory compliance
• Effectiveness check of audit measures
• Development of proposals for the effectiveness check of two already completed audit measures
• Technical conception, support, and evaluation of the defined effectiveness checks
• Technical advice to the responsible stakeholders regarding possible implementation measures
• Documentation of the results of the effectiveness checks, including technical recommendations for action

Requirements

• Several years of experience in quality management and process management in regulated industries, especially medical technology and/or pharmaceuticals
• Experience in the design and evaluation of regulatory relevant contractual relationships, ideally including support in contract negotiations
• Very good German and English skills, spoken and written
• Sound knowledge of ISO 13485
• Knowledge of South African medical device regulations, especially the "Medicines and Related Substances Act 101" and the "Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices No. 1515"
• Experience in designing international sales and supply chain processes, ideally with reference to the South African market

Project details

• Start: flexible
• Duration: 4 Monate
• Remote: hybrid
• Location: Mannheim, Deutschland, DE
• Languages: German