
Senior Regulatory Compliance Specialist
3 days ago
Job Overview
We are seeking a Quality Assurance Specialist to join our team. In this role, you will be responsible for implementing and maintaining a Quality Management System (QMS) that ensures our products meet quality, safety, and regulatory standards.
Key Responsibilities:
- Implementing and maintaining a QMS in accordance with ISO standards
- Ensuring regulatory compliance by identifying, interpreting, and adhering to relevant medical device regulations
- Creating, reviewing, and controlling technical files, regulatory submissions, and quality agreements
- Providing QA/RA input and support for design and development activities
- Participating in risk management activities throughout the product life cycle
- Monitoring device performance in the market and investigating customer complaints and non-conformity
- Supporting the management of supplier quality and compliance
Requirements:
- Regulatory expertise with deep knowledge of global medical device regulations and standards
- Problem-solving and attention to detail with ability to interpret regulations and resolve issues
- Strong communication skills with ability to coordinate with internal departments and external stakeholders
- Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline
- Previous experience in QA/RA within the medical device industry is an advantage
Why You'll Love This Role
This is a unique opportunity to work in a dynamic and fast-paced environment where you can make a real impact on our products and services. As a Quality Assurance Specialist, you will have the chance to develop your skills and expertise in a rapidly evolving industry.
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