Quality Assurance Manager
Há 6 dias
We are a global team of 66,000 dedicated employees across over 70 countries, passionate about pushing the boundaries of what's possible in healthcare to improve people's lives worldwide.
Our Culture:
- We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible to improve people's lives around the world.
- We embrace a culture of inclusivity where the power and potential of every individual can be unleashed.
- We spark ideas that lead to positive impact and continued success.
Your Responsibilities:
- Provide support to the Quality Department on QM/RA topics, including maintenance of certification processes and regulatory compliance.
- Ensure compliance with all regulatory processes, in readiness for both internal and external audits.
- Contribute to the regulatory activities performed, including pre-market notifications and post-market surveillance activities.
- Document and track regulatory submissions and regulatory authority requests/approvals.
- Perform general regulatory administration duties and compliance requirements.
About You:
- Degree/Master's in Life Sciences, ideally a Pharmacy Degree.
- Fluency in English and Portuguese.
- At least 1 year of experience in RA in a Medical Device Company.
- Knowledge of Quality Management, ISO standards, and medical device regulations.
- A digital mindset and a keen interest in new healthcare technologies.
- Structured way of thinking with an eye for details and critical thinking.
- Hands-on mentality, independence, strong analysis and documentation skills, good teamwork in a cross-functional environment.
- Good communication skills, learning seeker, team worker, initiative.
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