Clinical Scientist

Job Title: Clinical Scientist – Design Controls Remediation

Location: Remote (United States – Remote within the U.S. only)

Employment Type: Contract (W2 Only)

Duration: Not specified (Contract assignment duration to be confirmed by hiring team)

Salary/Rate

$40–$45 per hour (W2)

This pay range represents a good-faith estimate of the compensation for this role at the time of posting. Actual compensation may vary based on factors such as experience, education, and relevant skill set, and will comply with applicable federal, state, and local wage laws.

Benefits

Contract = no employer-provided benefits

Job Summary

We are seeking an experienced Clinical Scientist to support a Design Controls Remediation initiative within a regulated medical device environment. This role focuses on evaluating and strengthening clinical evidence supporting design inputs, risk management files, and verification and validation (V&V) activities. The Clinical Scientist will ensure that clinical claims, risk-benefit justifications, and clinical evaluation documentation are scientifically robust, traceable, and aligned with applicable regulatory requirements. The ideal candidate will have strong expertise in clinical evaluation, literature analysis, and regulatory-compliant documentation to support remediation efforts and product lifecycle compliance.

Responsibilities

• Conduct gap assessments of clinical evidence supporting Design Inputs, risk management files, and clinical evaluation documentation (e.g., CEP/CER).

• Review and remediate clinical evaluation plans and clinical evaluation reports in alignment with applicable regulatory standards.

• Develop and update clinical risk-benefit analyses and support post-market surveillance (PMS) planning.

• Support V&V strategies incorporating clinical endpoints, simulated-use testing, and usability considerations.

• Ensure traceability between clinical evidence, design inputs, risk controls, and validation activities within the Design History File (DHF).

• Collaborate cross-functionally with Clinical, Regulatory, Quality, Pre-Clinical, and R&D teams.

• Perform clinical literature reviews and data analyses to support remediation and regulatory justification.

• Prepare technical clinical summaries and documentation to support regulatory submissions.

• Ensure compliance with applicable standards and guidance, including ISO 14155 and FDA clinical evidence expectations.

Required Qualifications

• Advanced degree (Master’s or PhD) in Biomedical Sciences, Clinical Research, Life Sciences, or related field.

• Demonstrated experience in medical device clinical science or clinical evaluation.

• Strong understanding of Design Controls, DHF, and clinical inputs to product development.

• Experience with clinical evidence generation, evaluation, and documentation (e.g., CER, literature reviews).

• Knowledge of applicable regulatory frameworks, including ISO 14155 and FDA clinical requirements.

• Experience supporting clinical aspects of risk management in alignment with ISO 14971.

• Strong scientific writing, data interpretation, and technical documentation skills.

• Excellent communication and cross-functional collaboration skills.

Work Requirements

• Must be legally authorized to work in the United States.

• Remote work is limited to candidates physically located within the United States.

• Ability to work W2 contract engagement structure.

• Compliance with client onboarding, background screening, and project documentation requirements as applicable.

Equal Opportunity Employer

The employer is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other status protected under applicable federal, state, or local law.

Application

Qualified candidates are encouraged to submit an updated resume highlighting relevant experience in clinical evaluation, design controls, and medical device regulatory compliance. Availability and hourly rate expectations should also be included.