Group Regulatory and Quality Specialist

3 semanas atrás


Lisboa, Portugal Shamir Optical Lda Tempo inteiro

General Responsibility
- Support in the implementation of ISO 13485 (Medical Device Certification) according to group strategy and plan;
- Support in the Quality Management for ongoing tasks related to Quality Europe Project with a mindset of continuous improvement;
- Support in the implementation and monitoring of regulatory strategies and processes to assure product and business compliance;
- Provide regulatory support to Shamir sites in terms of Medical Device Regulations and PPE Regulation;
- Review and validation of internal documentation in regard to regulatory requirements (e.g. product markings, labelling/packaging, marketing materials, technical files, artworks);
- Gather relevant data to inform the decision makers regarding quality and regulatory topics;
- Keep up to date with changes in Medical Device and PPE legislation, guidelines and standards to support, advice and train the relevant parties;
- Communication with Notified Bodies, External testing labs and Shamir external suppliers as needed.

Job demands
- Knowledge/experience with ISO 13485 & ISO 9001;
- Knowledge/experience of Medical Device Regulation and PPE Regulation;
- Document writing, prepare Presentations, Reports, CAPA, KPI’S.

Personal Qualifications
- University degree (Quality background - advantage)
- Experience of 1-2 years in the medical device industry - advantage
- Fluency in English (mandatory)
- Self-learner
- Organizational skills and detail oriented
- Good interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships
- Ability to work individually or in collaboration with others to accomplish tasks
- Computer literate with good working knowledge of the MS Office package
- Ability to travel occasionally, both international and domestic

Report to - Global Regulatory Compliance & Quality Europe Manager

Location - HQ / Hybrid work with office in Almada (Metropolitan Lisbon area)

**Tipo de oferta**: Integral/Full-time

Salário: 1.200,00€ - 1.500,00€ por mês

Horário de trabalho:

- Período diário



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