Regulatory Affairs Specialist

Grifols; Comunidad Valenciana; Híbrido; EUR 30.000 - 60.000; Jornada completa

Descripción de la vacante

Una empresa global de atención médica busca un Especialista en Asuntos Regulatorios para unirse a su equipo técnico. En esta emocionante posición, serás responsable de ofrecer apoyo en las funciones regulatorias y la gestión de dispositivos médicos. Con un enfoque en la mejora continua y el cumplimiento de normativas, tendrás la oportunidad de trabajar en un entorno colaborativo que valora la diversidad y el desarrollo profesional. Si tienes experiencia en procesos regulatorios y deseas contribuir a la salud y bienestar de millones, esta es la oportunidad perfecta para ti.

Servicios

Horario flexible

Ambiente de trabajo excelente

Desarrollo profesional

Formación

• 2 años de experiencia en un rol similar en la industria farmacéutica o dispositivos médicos.
• Conocimiento de procesos regulatorios para dispositivos médicos.

Responsabilidades

• Revisar contenidos de procesos e instrucciones del sistema de calidad.
• Coordinar la obtención de documentación certificadora de productos.

Conocimientos

Conocimientos en procesos regulatorios

Comunicación efectiva

Trabajo en equipo

Orientación a resultados

Atención al detalle

Educación

Licenciatura en Ciencias de la Vida

Herramientas

Microsoft Office

Excel

Descripción del empleo

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

We are looking for a Regulatory Affairs Specialist to join the Technical department at Grifols Movaco SA.

The main mission will be to provide support related to the regulatory functions and management of medical devices from external suppliers that are imported and distributed by Grifols Movaco SA.

What your responsibilities will be

• Review the content of the processes, instructions and records that are part of the quality system related to compliance with applicable regulations and directives.
• Coordinate and supervise the obtaining of the documentation certifying products and their manufacturers, importers and/or distributors.
• Review the documentation certifying products and their manufacturers, importers and/or distributors.
• Prepare, review, follow up, communicate and archive the documentation generated/required for the import and/or distribution process of medical products.
• Carry out the necessary communications for the marketing and commissioning of medical devices.
• Provide the department with regulatory advice to ensure compliance with current regulations.
• Maintain and manage the communications made in the national registry.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's Degree in Life Sciences field is preferred.
• Knowledge and experience in regulatory processes for medical devices, as well as the ability to coordinate and supervise the obtaining of the certifying documentation.
• 2 years of experience in a similar role within the pharma industry and/or medical devices.
• Advanced level of English.
• User of Microsoft Office tools, especially Excel.
• Meticulous and detail-oriented.
• Excellent communication and teamwork skills, as well as initiative and results orientation.

What we offer

It is a brilliant opportunity for you; Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!

We look forward to receiving your application!

Grifols is an equal opportunity employer.

Flexibility for U Program: Hybrid Model

Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.

Benefits package

Contract of Employment: Permanent position