
Medical Device Compliance Specialist
2 days ago
Job Description:
- Define the strategic direction and compliance-focused features for Electronic Device History Record (EDHR) platforms to ensure regulatory standards.
- Translate regulatory frameworks (21 CFR Part 820, EU MDR, ISO into digital product specifications that meet business objectives.
- Lead the integration of EDHR with MES, PLM, and QMS systems in medical device manufacturing environments to drive efficiency.
- Support technical pre-sales, audits, and validations to guarantee adherence to regulatory requirements.
Key Responsibilities:
- Serve as Subject Matter Expert (SME) for global medical device manufacturing compliance (DHF, DHR, MDR).
- Prioritize and manage product backlog aligned with regulatory demands and business value.
- Collaborate with cross-functional teams to ensure agile delivery of validated digital solutions.
- Drive continuous improvement and regulatory readiness through digital transformation initiatives.
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