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