
Device Compliance Specialist
4 days ago
Our organization is seeking a skilled Senior Device Engineer to drive the assessment and auditing of medical devices, ensuring compliance with regulatory requirements.
- Lead assessments and audits of medical devices to ensure compliance with regulatory requirements
- Develop and maintain expertise in relevant regulations and standards
- Collaborate with cross-functional teams to identify and mitigate risks
- Conduct thorough risk management analyses using EN ISO 14971
- Work closely with colleagues to ensure high-quality work products
Key Qualifications:
- Minimum 10 years of professional experience in healthcare or related field
- 5+ years of experience in quality management is essential
- Strong knowledge of non-active devices and sterilization processes
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