Group Regulatory and Quality Specialist
3 semanas atrás
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
-
Regulatory Affairs and Quality Assurance Specialist
1 semana atrás
Lisboa, Lisboa, Portugal MSD Tempo inteiroJob Description:The Regulatory Affairs and Quality Assurance Specialist has as primary task to take care of the Quality Assurance and Regulatory Affairs activities of the RA Unit. The position is related to veterinary medicinal products.Role in the organizationThe Regulatory Affairs and Quality Assurance Specialist has contact with stakeholders inside and...
-
Regulatory Affairs
2 meses atrás
Lisboa, Portugal HAYS Tempo inteiroEmpresa internacional da Indústria Farmacêutica integra Regulatory Affairs & Quality Assurance Specialist! A empresa onde vai trabalhar Integre uma empresa internacional da Indústria Farmacêutica, assumindo a função de Regulatory Affairs & Quality Assurance Specialist na zona da Grande Lisboa. A sua função Este profissional será responsável por...
-
Quality Assurance
1 semana atrás
Lisboa, Portugal HAYS Tempo inteiroEmpresa internacional da Indústria Farmacêutica procure Quality Assurance & Regulatory Affairs Specialist! A empresa onde vai trabalhar Integre uma empresa internacional da Indústria Farmacêutica como Quality Assurance & Regulatory Affairs Specialist! A sua nova função Este profissional será responsável por gerir as atividades ligadas aos Assuntos...
-
Quality Assurance
3 semanas atrás
Lisboa, Portugal Hays Tempo inteiroDescrição da Função Your new company Excellent opportunity to join an international company, leader in their sector, who is looking for a Quality Assurance / Regulatory Affairs Specialist in Medical Devices area. Your new role This professional will be responsible to ensure the correct application of the EU Medical Device Regulation 745/2017, and...
-
Regulatory and Start Up Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Novasyte Tempo inteiroJob OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Fluent in both Portuguese and English. At least 1 years'...
-
Senior Specialist, Quality Assurance Auditor
1 semana atrás
Lisboa, Lisboa, Portugal Organon Tempo inteiroSenior Specialist, Quality Assurance Auditor Lisboa Senior Specialist, Quality Assurance AuditorLisboa Lisboa, Lisboa, Portugal Job Description The Position The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides...
-
Senior Regulatory Affairs Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Hovione Tempo inteiroJoin a Market Leader:Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical...
-
Regulatory and Start Up Specialist
3 semanas atrás
Lisboa, Portugal Novasyte Tempo inteiroJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Fluent in both Portuguese and English. At least 1 years'...
-
Senior Regulatory Affairs Specialist
4 semanas atrás
Lisboa, Portugal Bausch + Lomb Tempo inteiroRegulatory Affaris Specialist Medical Devices **JOB OVERVIEW**: **Regulatory Affairs**: Manages all regulatory activities in Portugal for the Bausch + Lomb medical devices portfolio. Leads local, regional, and global projects (as applicable) and performs all necessary regulatory activities for Bausch + Lomb medical devices. **Materiovigilance**: Ensures...
-
Senior Regulatory Affairs Specialist
3 semanas atrás
Lisboa, Portugal Bausch + Lomb Tempo inteiroRegulatory Affaris Specialist Medical Devices **JOB OVERVIEW**: **Regulatory Affairs**: Manages all regulatory activities in Portugal for the Bausch + Lomb medical devices portfolio. Leads local, regional, and global projects (as applicable) and performs all necessary regulatory activities for Bausch + Lomb medical devices. **Materiovigilance**: Ensures...
-
Market Access and Regulatory Advisor
2 meses atrás
Lisboa, Portugal MCR International Tempo inteiroJLF-2307-152 MARKET ACCESS AND REGULATORY ADVISOR LISBON Purpose of the position: - Responsible for developing, communicating and executing market access strategy with local/regional Business Groups and with Global Regulatory Partners, aligned with the company’s global regulatory strategy. - Prepare all the submission prices dossiers and...
-
Market Access and Regulatory Advisor
1 semana atrás
Lisboa, Lisboa, Portugal MCR International Tempo inteiroJLFMARKET ACCESS AND REGULATORY ADVISORLISBONPurpose of the position: Responsible for developing, communicating and executing market access strategy with local/regional Business Groups and with Global Regulatory Partners, aligned with the company's global regulatory strategy. Prepare all the submission prices dossiers and pharmacoeconomic justification for...
-
Junior Regulatory Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Apiax AG Tempo inteiroDo you want to have a meaningful impact on the financial services industry? If so, then we have a great opportunity for you. We're looking for a Junior Regulatory Specialist to join our RegTech company. You are a legal & compliance professional who is technologically adept with financial markets regulation. You see the opportunity to improve tax, legal,...
-
Junior Regulatory Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Apiax AG Tempo inteiroDo you want to have a meaningful impact on the financial services industry? If so, then we have a great opportunity for you.We're looking for a Junior Regulatory Specialist to join our RegTech company.TasksWhat you will be tasked to do:Acting as the interface between regulatory and technology experts Structure global financial industry regulation with our...
-
Lisboa, Portugal Organon Tempo inteiro.Senior Specialist, Quality Assurance Auditor Lisboa Senior Specialist, Quality Assurance AuditorLisboa Lisboa, Lisboa, Portugal Job Description The Position The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides...
-
Senior Specialist, Quality Assurance Auditor
1 semana atrás
Lisboa, Lisboa, Portugal bioM?rieux BV Tempo inteiroJob Description The Position The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and...
-
Regulatory and Start Up Specialist
1 semana atrás
Lisboa, Lisboa, Portugal Novasyte Tempo inteiroJob OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Portuguese and English language proficiency.Essential...
-
Junior Regulatory Specialist
Há 1 mês
Lisboa, Portugal Apiax Tempo inteiroDo you want to have a meaningful impact on the financial services industry? If so, then we have a great opportunity for you. We're looking for a** Junior Regulatory Specialist **to join our RegTech company. **What you will be tasked to do**: - Acting as the interface between regulatory and technology experts - Structure global financial industry...
-
Commercial Quality Specialist
4 semanas atrás
Lisboa, Portugal Kenvue Tempo inteiro**Commercial Quality Specialist**-2307006749W Description The Commercial Quality (CQ) Specialist is responsible for implementation and maintenance of the appropriate Quality Standards and Systems for the operation of the Portuguese Consumer Health organization. It will also be responsible for partnering with the Portugal Business Head and Management in...
-
Junior Regulatory Specialist
Há 3 dias
Lisboa, Portugal Apiax Ag Tempo inteiroDo you want to have a meaningful impact on the financial services industry? If so, then we have a great opportunity for you.We're looking for a Junior Regulatory Specialist to join our RegTech company.You are a legal & compliance professional who is technologically adept with financial markets regulation. You see the opportunity to improve tax, legal,...