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Clinical Project Manager
2 months ago
We are seeking a highly skilled Clinical Project Manager to join our team at Aylesbury. As a key member of our organization, you will play a critical role in bringing life-changing medical devices to market, ensuring they meet the highest regulatory standards and are backed by robust clinical evidence.
Key Responsibilities- Project Management: Lead regulatory and clinical projects, including MDR submissions, new product introductions, and foreign market registrations. Manage CAPAs and maintain project documentation.
- Regulatory Compliance: Maintain Medical Device Files, support regulatory audits, and provide guidance to cross-functional teams.
- Clinical Oversight: Collaborate with external consultants, conduct literature reviews, and prepare regulatory documents like Clinical Evaluation and Post Market Surveillance Report.
- Project Management: PRINCE2 or another recognized project management qualification. A disciplined, detail-oriented approach to managing projects and timelines is essential.
- Writing Skills: Proficient in scientific and medical writing, particularly in Clinical Evaluation Reports (CER).
- Regulatory Knowledge: In-depth understanding of clinical evaluation guidelines and regulations, including MEDDEV 2.b.
- Career Growth: We offer a clear path for career advancement, with opportunities to lead high-profile projects and take on more significant responsibilities within the organization.
- Professional Development: You'll have access to ongoing training and development programs, including support for certifications and attendance at industry conferences, to keep you at the forefront of regulatory and clinical expertise.
- Work-Life Balance: We understand the importance of balance and offer flexible working arrangements to help you manage your professional and personal life effectively.
