Hiring - Pre-Clinical SME – Design Controls Remediation
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Sravan Kumar
Apr 1, 2026, 2:42:34 PM (2 days ago) Apr 1
to Sravan Kumar
Role: Pre-Clinical SME – Design Controls Remediation
Location: Remote
Duration: 12 months
Any Visa
Client: Hologic
Note: This is a US requirement – candidates must be authorized to work in the United States.
Role Summary
The Pre-Clinical SME will lead gap assessments and remediation of pre-clinical (bench, animal, biocompatibility) data supporting Design Inputs, Risk Management, and V&V for the medical device.
Responsibilities
• Evaluate gaps in pre-clinical testing plans, protocols, and reports against design control requirements.
• Support development or updating of biocompatibility, performance, and animal study documentation
• Integrate pre-clinical results into risk management files and verification/validation strategies.
• Provide technical justification for pre-clinical evidence in regulatory submissions.
• Collaborate with Clinical SME and Systems Engineers for holistic evidence alignment.
Qualifications
• Degree in Biomedical Engineering, or related field.
• Pre-Clinical testing experience in medical devices under ISO 10993 and GLP.
• Expertise in bench testing, animal models, and biocompatibility risk management.
• Experience with pre-clinical gap assessments and DHF remediation.
• Strong regulatory writing and data interpretation skills.
Location: Remote
Duration: 12 months
Any Visa
Client: Hologic
Note: This is a US requirement – candidates must be authorized to work in the United States.
Role Summary
The Pre-Clinical SME will lead gap assessments and remediation of pre-clinical (bench, animal, biocompatibility) data supporting Design Inputs, Risk Management, and V&V for the medical device.
Responsibilities
• Evaluate gaps in pre-clinical testing plans, protocols, and reports against design control requirements.
• Support development or updating of biocompatibility, performance, and animal study documentation
• Integrate pre-clinical results into risk management files and verification/validation strategies.
• Provide technical justification for pre-clinical evidence in regulatory submissions.
• Collaborate with Clinical SME and Systems Engineers for holistic evidence alignment.
Qualifications
• Degree in Biomedical Engineering, or related field.
• Pre-Clinical testing experience in medical devices under ISO 10993 and GLP.
• Expertise in bench testing, animal models, and biocompatibility risk management.
• Experience with pre-clinical gap assessments and DHF remediation.
• Strong regulatory writing and data interpretation skills.
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