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Senior QA/RA Specialist - Remote & Impactful Compliance
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Senior QA/RA Specialist - Remote & Impactful Compliance
Resumo da oferta
A medical device company is seeking a Senior QA/RA Specialist for Quality Assurance. This role entails ensuring compliance with management systems and regulatory frameworks, coordinating quality activities, and managing regulatory submissions. Candidates should have a Bachelor's degree and experience in regulatory affairs related to medical devices. The position offers a supportive and dynamic work environment, along with a bonus plan and work from home flexibility.
Serviços
Qualificações
- At least one year of experience in regulatory affairs or quality management systems for medical devices.
- Strong experience in Quality Systems and Medical Device Regulation (MDR 2017/745).
Responsabilidades
- Ensure compliance with quality management systems and regulatory frameworks.
- Coordinate complaint handling and investigations.
- Support design quality rigor and oversee product quality.
- Manage regulatory submissions and maintain regulatory records.
Conhecimentos
Formação académica
* O salário de referência é obtido com base em objetivos de salário para líderes de mercado de cada segmento de setor. Serve como orientação para ajudar os utilizadores Premium na avaliação de ofertas de emprego e na negociação de salários. O salário de referência não é indicado diretamente pela empresa e pode ser significativamente superior ou inferior.