Medical Device Clinical Associate
5 days ago
Job Title: Medical Device Clinical Associate
Job Description:
- This position focuses on coordinating and supporting clinical research to ensure product safety, efficacy, and regulatory compliance as well as supporting the planning, and execution of Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), Clinical Evaluation Plans (CEP), and Periodic Safety Update Reports (PSUR) / Post-market surveillance reports (PMSR).
- The ideal candidate should possess a strong understanding of regulatory compliance and clinical research methodologies.
Key Responsibilities:
- Support day-to-day operations of assigned studies, ensuring adherence to protocol requirements, and timelines.
- Act as a contact for site staff and ensure clear communication regarding study updates.
- Assist in the creation and execution of Clinical Evaluation Plans (CEP) for new and existing medical devices, including designing strategies to collect relevant clinical data and determining appropriate methodologies for product assessment.
Requirements:
- Bachelor's degree in life sciences, healthcare, or a related field.
- 1-2 years of experience in clinical research/clinical affairs, within the medical device, healthcare industry, or CRO setting.
- Knowledge of FDA, EU MDR, ICH-GCP, ISO 14155, IRB, and ISO 13485 regulations.
Estimated Salary: $60,000 - $75,000 per year
Benefits:
- A competitive salary and benefits package.
- Opportunities for professional growth and development.
- A collaborative and dynamic work environment.
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