
Medical Device Regulatory Compliance Specialist
7 days ago
Key Responsibilities
- We maintain and implement a Quality Management System to ensure our products meet quality, safety, and regulatory standards.
- Our team ensures adherence to relevant medical device regulations for market entry and ongoing compliance.
- We provide QA/RA input and support for design and development activities to guarantee compliance from the outset.
Essential Skills & Qualifications
- A deep understanding of global medical device regulations and standards is crucial.
- Problem-solving and attention to detail are essential for interpreting regulations, documenting processes, and resolving issues.
- Effective communication skills help us coordinate with internal departments and external stakeholders.
- A Bachelor's Degree in a relevant field such as engineering, life sciences, or a related technical discipline is required.
- Prior experience in QA/RA within the medical device industry is highly advantageous.
- Maintaining product documentation and ensuring compliance throughout the product lifecycle.
- Collaborating with cross-functional teams to identify and address process improvements.
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