Regulatory Affairs Manager en Barcelona.

14 Feb 2020 publicado por Professionals

tipo de contrato
jornada laboral
sector empresa
Química Farma
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responsable registros / regulatory affairs
Life Sciences
Pharma y Biotech - Medico
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Multinational laboratory equipment company

our client

Multinational laboratory equipment company

your functions
This position provides effective regulatory support for company¿s manufactured products
and customer¿s products. Prepare and submit the documentation according to the
corresponding legislation for the different countries.
Be responsible for the implementation of new regulatory requirements.
Key Accountabilities
¿ Prepare the required documentation to obtain the CE mark, FDA or other country
registrations for the company¿s manufactured products or customer¿s products in
accordance to the current legislations.
¿ Prepare international registration documentation (technical and legal) for the
customer¿s products.
¿ Support customers with any regulatory aspect.
¿ Follow-up and resolve the requirements emerged in the registration procedures.
¿ Support internal and external audits, validations and product¿s risk analysis.
¿ Follow management indicators for the proper performance of the department and
apply, if necessary, the appropriate corrective actions.
¿ Support to the Market Surveillance Department in the compilation of information for
the Post Market Surveillance.
¿ Act as main company point of contact for all REACH and related legislative matters.
¿ Coordinate efforts associated with the preparation of REACH regulatory documents
or submissions.
¿ Recommend changes to company procedures in response to changes in regulations
or standards.
¿ Maintain technical files as necessary to sustain product approval.
¿ Review product materials, labeling and/or specification sheets for compliance with
applicable regulations and customer¿s policies.
¿ Prepare Safety Data Sheet for the different products.
position requisites

The ideal candidate for this position will exhibit the following skills and
o Communicative
o Flexible to adapt to the task changes when necessary.
o Methodical and organized.
o Teamwork skills.
o Quality oriented
o Operational and action-oriented

Min Knowledge & Experience required for the position:
¿ Education: MSc in Biotechnology, other sciences or related fields
¿ Experience:
o Heathcare regulatory background
¿ Additional Skills/Knowledge:
o Knowledge of IVD legislation and Healthcare sector.
o Language: High level of English (oral and written)

  • Formación: Licenciado: Biotecnología
  • Experiencia: 5 años
your benefits

Permanent Vacancy.

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