Technical Office Manager
Exciting opportunity with Igenomix - Pioneers in advanced reproductive genetic testing.
At IGENOMIX we provide advanced services in reproductive genetics. Our broad experience and qualifications make us the global leader in this field. The constant efforts we make in R&D;, enable us to create and develop specific tools to support professionals in the reproductive medicine area.
Igenomix is part of Vitrolife Group, Vitrolife is an international medical device and genetic services Group. Vitrolife develops, produces and markets products for reproductive health together with services that provide personalised genetic information to improve clinical practices in infertility, women’s health and rare diseases. Headquartered in Gothenburg, Sweden, the Group currently employs approximately 1,200 people worldwide. Its products, services and solutions are available in more than 110 markets through a network of subsidiaries and distributors. The Group has wide-ranging experience in the fertility field with an advanced research capacity. The Vitrolife share is listed on NASDAQ Stockholm.
Key Responsibilities
- Planning of activities of the Technical Office
- Management of compliance with IVDR regulations
- Back-up of the person responsible for regulatory compliance with the IVDR standard
- Services Documentation of genetic services’ design
- Planning and control of critical reagents
- Planning and execution of transfer to production of new developments
- Implementation of genetic services in Spain and Affiliates
- Management of _control of change_ processes
- Planning of control of genetic services’ performance
- Design and execution of internal audits of services’ performance
- Planning and monitoring of Post-Market Performance Follow-up
- Technical assistance and support to laboratories
What will you need as a successful Technical Office Manager?
- Degree or PhD in Biology, Biochemistry, Biotechnology, Biomedicine or related.
- 5 years of previous experience as a supervisor, operations manager, diagnosis manager or technical manager in a genetic analysis laboratory.
- Demonstrable experience and competence in project management tasks.
- Experience and technical and practical knowledge in quality management systems, medical device and medical device for _in vitro_ diagnosis will be valued.
- Ability to manage people teams.
- Communication skills with other departments, affiliates, and suppliers.
- Ability to work independently.
- Planning, time management and organization skills.
- B2 or higher level of spoken and written English.
Nice to have skills and experience:
- Knowledge of molecular techniques for genetic analysis
- Knowledge of national and international regulation for medical devices
Manager para Oficina Técnica
Experiência:
- Experiência competente previa: al menos 5 años como supervisor, responsable de operaciones, responsable de diagnóstico o responsable técnico en laboratorio de análisis genéticos.
- Experiência demostrable y competencia en tareas de gestión de proyectos.
- Se valorará experiência y conocimiento técnico y práctico en gestión de sistemas de calidad, producto sanitario y producto sanitario para diagnóstico _in vitro_.
- Capacidad para gestionar personas a su cargo. Habilidades de comunicación y gestión de proyectos con otros departamentos, filiales y proveedores.
- Capacidad para trabajar con mínima supervisión. Habilidades de planificación, gestión del tiempo y organización.
- Buen nível de inglés hablado y escrito.
**Responsabilidades**:
- Planificación de actividades de la Oficina Técnica
- Gestión de cumplimiento de normativa IVDR
- Back-up de persona responsable de cumplimiento de la norma IVDR
- Documentación diseño servicios
- Planificación y control de reactivos críticos
- Planificación y ejecución de transferencia a producción de nuevos desarrollos
- Implementación de servicios en España y filiales
- Gestión del cambio
- Planificación de control de funcionamiento de servicios
- Diseño y ejecución de auditorías internas de funcionamiento de servicios
- Planificación y seguimiento de Post-Market Performance Follow-up
- Asistencia técnica y soporte a laboratorios
Conocimientos específicos
- Alto grado de conocimiento de técnicas moleculares para análisis genético
- Alto grado de conocimiento en regulación nacional e internacional de producto sanitario
- Buen conocimiento de inglés
- Conocimiento de gestión de proyectos
Tipo de puesto: Jornada completa