Regulatory, Quality & Safety Specialist

Psicotec

  • Valencia
  • Permanente
  • Tiempo completo
  • Hace 4 meses
  • Solicite fácilmente
Job Description:

RQ&S specialist is the main responsible in the country to deal with regulatory, quality protocols, MDR´s protocols & side effects.

ACCOUNTABILITIES :

➢ Regulatory Follow-up:
  • Local regulatory watch, including:
o PMS & MD vigilance

o National health authorities website surveillance (ie FSA, Field Safety Action publication regarding dermal fillers).
  • National competent local point of contact
  • 1st placing on the market declaration
  • Coordination / validation packaging, leaflet & promotional documents
  • Supervise the local reworks.
  • Ensure the compliance of the new regulatory obligations assigned to the distributor introduced in the Medical Device Regulation MDR (2017/745) before placing the product on the market.
➢ Quality & control follow-up:
  • Supervise and update the local QMS in compliance with requirements
  • Participation in the improvement of processes, procedures, instructions, forms, tools and database in relation with the Quality Department.
  • Participation to audits.
  • Analysis and follow-up of temperature control during transport and storage
  • Ensure that the batches traceability is respected.
  • Reception controls
  • Follow up NCF, changes and CAPA
  • Follow up the local trainings on this subject to employees.
  • To be responsible in case of batch recall.
  • To manage the box system (documents follow up, implementation)
➢ Side effects follow up:
  • Point of contact for Side effects locally.
  • Responsible to report to AEMS & all internal procedures.
  • Contribute / be the liasing person for the smooth follow up of side effects
  • Participate to Medical Educational trainings and advisory boards wherever applicable.
Requirements
  • Scientific training
  • Experience in the Medical Device industry
  • QSM & PMS skills
  • Regulatory & clinical knowledge
  • Fluent English
  • Good writing & communication skills
  • Control of MS Office

Psicotec

Empleos similares

  • Data Quality

    Sothis

    • Paterna, Valencia
    Sothis ¿Cómo somos? En Sothis nos caracterizamos por ser Personas con Pasión, Mente Abierta y Esfuerzo, lo que nos ha convertido en un gran equipo. Nuestras Personas están en el …
    • Hace 25 días
  • Product Quality Clinican

    Edwards Lifesciences

    • Valencia
    Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks. The Product Quality Clinician is …
    • Hace 1 mes
  • TS Dispatching Specialist

    Baxter

    • Valencia
    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the …
    • Hace 7 días