NEWPosted 3 hours ago
Job ID: JOB_ID_5464
We are actively hiring multiple professionals for a large-scale Design History File (DHF) Remediation program within the Medical Devices industry. If you have experience in design controls, risk management, verification & validation, or regulatory/clinical functions, this is a great opportunity to work on high-impact regulatory remediation projects.
- Open Roles:
- Risk Management Specialist – Design Controls Remediation
- Design Validation Workstream Lead – DHF Remediation
- Design Inputs Workstream Lead – DHF Remediation
- Verification SME – Design Controls Remediation
- Systems Engineer – Design Controls Remediation
- Clinical Scientist – Design Controls Remediation
- RA (Regulatory Affairs) Team Lead
- Design Outputs Workstream Lead – DHF Remediation
- Design Verification Workstream Lead – DHF Remediation
- Key Skills We’re Looking For:
- Strong experience in medical device design controls (DHF)
- Knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820 / QMSR
- Expertise in Risk Management, Verification & Validation (V&V), Traceability
- Experience in remediation / gap assessment programs
- Cross-functional collaboration across QA, RA, Engineering, and Clinical teams
- Domain: Medical Devices
- Work Type: Remote
These roles are ideal for professionals who have worked on regulatory remediation, audit readiness, or legacy product DHF corrections.
Special Requirements
Work Type: Remote
Compensation & Location
Salary: $100,000 – $180,000 per year (Estimated)
Location: Remote
Recruiter / Company – Contact Information
Email: vannkumarr.5@gmail.com
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