Medical Device Compliance Expert
3 days ago
g2 Recruitment is seeking a Regulatory Affairs Professional to join their team. As a Quality Engineer, you will be responsible for ensuring the quality and compliance of medical devices developed for drug delivery systems.
Main Duties:- Review and develop quality procedures and documentation.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Conduct risk assessments and support design control activities.
- Maintain and review documentation for regulatory compliance.
- Support audits and change management processes.
The ideal candidate will have a strong background in quality engineering and a passion for delivering high-quality solutions.
Qualifications:- Bachelor's degree in Engineering or a related field.
- 3+ years of experience in quality engineering (medical device or pharma).
- Knowledge of ISO 13485, FDA regulations, and risk management.
- Excellent communication and problem-solving skills.
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