
Medical Device Compliance Specialist
3 days ago
A Quality Assurance Specialist is responsible for implementing and maintaining our Quality Management System, ensuring that products meet quality, safety, and regulatory standards.
">This role involves creating, reviewing, and controlling technical files, regulatory submissions, quality agreements, and internal procedures.
">The successful candidate will identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
">Key Responsibilities:- Implement and maintain Quality Management System (QMS)
- Ensure product quality, safety, and regulatory standards
- Create, review, and control technical files
- Support regulatory submissions and quality agreements
Required Skills and Qualifications:
">Deep knowledge of global medical device regulations and standards is required. Problem-solving skills and attention to detail are crucial for this role.
">A Bachelor's Degree in a relevant field such as engineering, life sciences, or a related technical discipline is necessary.
">Previous experience in QA/RA within the medical device industry is an advantage.
">Benefits:- Opportunity to work with a leading company in the medical device industry
- Collaborative team environment
- Professional development opportunities
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