Support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen. Key Accountabilities Support RAQA management with a business focus. Ensure compliance with RAQA record management processes. Lead and manage non-conformities, follow-up plans for CAPAs. Document tracking and control in SAP. Regulatory submissions to INVIMA and other regulatory entities. Preparation and updating of quality agreements. Management of regulatory and quality databases. Follow-up on regulatory processes with the factory. Follow-up and preparation of meeting and committee minutes. Provide technical and sanitary product documents. Issue letters to customers. Review registration requests received in detail and provide appropriate responses and support to stakeholders. Managed Budget (if applicable) & KPI Ensure timely submission of regulatory dossiers. Track regulatory plans and quality assurance planning (audit plan, training plan, document management plan, change management, and risk management). Generate improvement proposals, continuous development, and involvement in projects. Internal Networks/Key Relationships To be determined based on departmental needs, including interactions such as: Customers External suppliers (logistics operator, certifying entities, INVIMA, ANDI, agen) Marketing managers Department managers/directors General Manager Commercial team Specialists and technical support team Clinical specialists Skills and Abilities: The ideal candidate for this position will exhibit the following core competencies: Analytical skills Numerical analysis Problem-solving Statistical knowledge Creativity Excellent interpersonal skills Integrity Good organizational skills Ability to work under pressure Teamwork Good interpersonal skills and a good listener Proactivity Results-oriented Minimum Knowledge and Experience Required for the Position: Education: Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering. Experience: Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry. Additional skills/knowledge: Computer skills, including Word, Excel, and PowerPoint. Language: Intermediate English. Knowledge of ISO 13485 and/or ISO 9001-2015. Clinical Applications Consultant: Autoimmunity, North Central Territory Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a... Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a... Overview Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a... #J-18808-Ljbffr