Coordinate the preparation of an up-to-date Technical Dossier, Design History File, in accordance with the relevant regulatory requirements and standards for relevant jurisdictions (e.g. EU, USA, Canada) for all TIO’s products.
Contribute to the QA&RA strategy related with a global marketing strategy of the TIO / Quirem Medical products, including defining the relevant regulatory frameworks and the product registration and technical documentation requirements.
Maintain up-to-date QMS-documentation under responsibility of the QA/RA department. Proposes and implements optimizations where possible. Makes sure, procedural interactions within the QMS are identified and maintained in accordance.
Coordinate – multidisciplinary and regional or global – projects to maintain or obtain regulatory approval or compliancy, in accordance with the business needs in countries or regions where TIO / Quirem Medical’s products are or will be marketed.
Actively support the QA&RA manager in:
-Ensuring that the business remains compliant with local, federal and global quality system regulations applicable to the products manufactured, sourced by, distributed and installed or serviced by Quirem,
-Advising on Quality & Regulatory standards applicable to the business being served,
-Preparing GAP-assessments relevant for Quirem Medical’s business, resulting from new or changed Rules & Regulations or Standards,
-Coordinating, and executing GAP-closure projects/activities and changing existing or implement new procedures where required, consecutively,
-Resolving customer or supplier inquiries related with product quality- or regulatory affairs related matters.
Act as a senior expert in the Quality & Regulatory function by actively supporting the development of Quality systems
Maintain/prepare a training program and executes internal trainings
Review batch documentation and release intermediate and final products.
Ensure the proper implementation of and oversee CAPA (Corrective and Preventative Actions), validations, inspections, document control, regulatory affairs, and problem resolution, acting as an advisor. Maintains an effective CAPA process and CAPA e-platform.
Coordinate and communicate in accordance and where needed, in response to customer complaints or in cases of serious incidents (including vigilance or field safety corrections related responsibilities).
Review & approve product documentation (including labeling) and product marketing literature for regulatory compliance and claims support.
Interface with external Quality Auditors and Regulatory Agencies during on-site audits and their follow-up. .