Regulatory Affairs Specialist IVD en San Sebastián de los Reyes, Madrid.
02 Jul 2021 publicado por Professionals
- 35.000-45.000 €/año
- tipo de contrato
- jornada laboral
- sector empresa
- Life Science
- ver más
- responsable registros / regulatory affairs
- San Sebastián de los Reyes
- Life Sciences
- Pharma y Biotech - Medico
- Combinada (teletrabajo y presencial)
- our client
We are seeking a Regulatory Affairs Specialist to support our national Regulatory Affairs department as well as our Central Regulatory Affairs team in our headquarters in Germany.
The Regulatory Affairs Specialist supports the planning and execution of regulatory activities for the registration of the assigned product portfolio. This position is actively supporting the product teams to make the products and related documentation compliant to the national and international requirements.
The Regulatory Affairs Specialist serves as a subject matter expert for creation of regulatory reports and regulatory requirements. He/she will drive results through being a well-organized team player with a focused and disciplined approach to achieve the joint goals.
- your functions
These are your new key responsibilities:
You actively support all pre-market and post-market regulatory activities of the assigned product portfolio
You keep track of the national and international requirements for product registrations
You work with the product teams to ensure the products and related documentation are compliant with the regulatory requirements
You support with national registrations and the regulatory transformation for compliance to the new EU IVD Regulation 2017/746.
You create registration dossiers used for registration at international authorities.
- position requisites
Bachelor of Science required in medical, biological, engineering or closely related science.
Master's degree and further education in Regulatory Affairs preferred.
Minimum of 2 years regulatory work experience in a medical device company and/or in vitro diagnostic device area
o Knowledge of regulations and standards (CFR, GCP, ICH, ISO, QSR, etc.) affecting IVDs
o Ability to deal with ambiguous situations, perform work effectively with a high degree of independent judgment without direct oversight with multi-level teams, manage and support multiple projects and resources in a fast paced and changing environment.
o Maintain knowledge of the medical, biological and technical / analytical aspects relevant to the products.
o Demonstrated and effective interpersonal, communication and negotiation skills
o Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates.
- Formación: Licenciado: Farmacia
- Idiomas: Inglés: ALTO
- Conocimientos: registros farmacéuticos, medical devices, IVD
- Experiencia: 2 años
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