Quality & Regulatory Affairs Specialist (m/f)
International reference group
Sobre o nosso cliente
International reference group.
Descrição da oferta
You will be responsible for:
- Implementing and maintaining the Quality Management System of the company;
- Ensuring the compliance with the requirement of ISO 13485 standard;
- Assist the company in regulatory submissions, annual reports, registrations and listings of medical devices with the local authority (Infarmed);
- Assure the compliance with applicable medical device regulations per jurisdiction, guidance and standards;
- Assist in the creation and maintenance of regulatory files.
- Minimum of 2 years of experience in the Medical Devices Industry;
- Good knowledge of ISO 13485 and ISO 9001 (Quality System) requirements, ISO 14971 (Risk Management);
- Familiar with Medical Device Directives 93/42/CE (MDD) and Medical Device Regulation 745/2017 (MDR) requirements;
- Familiar with ISO 62304, Medical Device Software - Software Life Cycle processes;
- Ability to analyse and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents;
- Excellent verbal and written communication skills;
- Effective problem-solving skills;
- Good English skills.
Great opportunity to join an international reference group with a solid structure and with career development perspectives.
Na Michael Page, acreditamos na Diversidade e Inclusão. Defendemos a igualdade de oportunidades sem discriminar por género, raça, ideia, religião, orientação sexual ou qualquer outro aspeto que possa ser considerado discriminatório ou de exclusão.