Clinical Evaluation Specialist
4 weeks ago
About the Role:
The Clinical Evaluation Specialist will play a critical role in driving the clinical evaluation process for medical devices, ensuring compliance with regulatory requirements and scientific accuracy. This position requires a strong understanding of clinical research, regulatory affairs, and scientific writing.
Key Responsibilities:
- Develop and implement clinical evaluation strategies for new product development cycles.
- Design and execute literature searches to retrieve published clinical data.
- Analyze and interpret clinical, PMS, marketing, and testing data to create comprehensive scientific reviews.
- Collaborate with Medical Experts to develop conclusions on the overall risk-benefit statement.
- Identify unanswered questions and residual risks in the Clinical Evidence and design Post Market Clinical Follow Up activities.
- Develop and maintain Clinical Evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.
- Support Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence.
Requirements:
- University degree (PhD, Master's or equivalent) in a field related to the life sciences or a relevant medical engineering field.
- 3 to 5 years of experience in Scientific or Medical Writing, and/or relevant academic or clinical research experience.
- Experience in clinical or regulatory affairs preferred.
- Proactive, independent, team player with a strong service mentality.
- Strong analytical and transdisciplinary reasoning skills with a good attention to detail.
What We Offer:
Stryker Global Technology Center Pvt Ltd. offers a dynamic and international working environment with opportunities for professional growth and development.
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