Clinical Evidence Manager
7 days ago
We are seeking a highly skilled Regulatory Affairs Team Leader to join our team at CV Library. As a key member of our Medical Device Regulatory team, you will play a critical role in ensuring the highest regulatory standards are met for our life-changing products.
Key Responsibilities:
- Regulatory Compliance: You will be responsible for ensuring all regulatory documents and submissions are accurate, complete, and compliant with relevant regulations.
- Clinical Evidence: You will identify, review, and summarize clinical evidence from various data sources to support regulatory documents and post-market surveillance.
- Document Preparation: You will prepare and review summaries, reports, and clinical documents to ensure regulatory compliance and support product registrations.
- CE/UKCA Marking: You will plan and deliver key documents for CE/UKCA marking under European Medical Device Regulations (MDR).
- Content Development: You will research, write, and review clinical/scientific materials and regulatory documents, including clinical study protocols, reports, and submissions to regulatory bodies.
Requirements:
- At least four years of professional experience in a Regulatory & Clinical setting relating to medical devices, with a high regard for the technical aspects of the functions.
- Sound experience in scientific/medical writing and regulatory affairs.
What We Offer:
- A competitive salary and benefits package.
- Ongoing training and development programs to keep you at the forefront of regulatory and clinical expertise.
- A collaborative and dynamic work environment.
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