Regulatory, Quality & Safety Specialist
Psicotec
- Valencia
- Permanente
- Tiempo completo
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 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.
- 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)
- 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.
- 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