Clinical Regulatory Project Leader
3 weeks ago
Regulatory and Clinical Project Manager
Location: High Wycombe - Hybrid (2 days remote after successful probation)
Compensation: Up to £67,500 plus Benefits
What We Offer:
- Meaningful Contributions: You will be instrumental in the launch of transformative medical devices, ensuring compliance with stringent regulatory requirements and supporting them with comprehensive clinical evidence.
- Opportunities for Advancement: We provide a structured pathway for career progression, allowing you to lead significant projects and expand your responsibilities within the organization.
- Continuous Learning: Gain access to ongoing training and development initiatives, including support for professional certifications and participation in industry conferences, to enhance your regulatory and clinical knowledge.
- Creative Work Environment: Collaborate with a skilled, multidisciplinary team in a company that prioritizes innovation, creativity, and ongoing improvement.
- Flexible Work Arrangements: We recognize the importance of work-life balance and offer adaptable working conditions to help you effectively manage your professional and personal commitments.
Key Requirements:
- Experience: At least 4 years in a Regulatory & Clinical role within the medical device sector, with a strong emphasis on technical functions.
- Educational Background: A degree in law, medicine, pharmacy, engineering, or a related scientific field.
- Project Management Skills: PRINCE2 or a similar recognized project management certification. A meticulous, detail-oriented approach to managing projects and timelines is essential.
- Writing Proficiency: Skilled in scientific and medical writing, particularly in Clinical Evaluation Reports (CER). Capable of conducting relevant clinical searches for our products.
- Regulatory Expertise: Comprehensive understanding of clinical evaluation guidelines and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.
- Leadership Experience: Demonstrated capability in line management and task delegation.
Responsibilities:
- Project Leadership: Oversee regulatory and clinical projects, including MDR submissions, new product launches, and international market registrations. Manage CAPAs and maintain project documentation.
- Regulatory Adherence: Maintain Medical Device Files, assist with regulatory audits, and provide guidance to cross-functional teams.
- Clinical Management: Work with external consultants, conduct literature reviews, and prepare regulatory documents such as Clinical Evaluation and Post Market Surveillance Reports.
Become part of a vibrant organization that values your expertise and is committed to your professional growth. This role offers a chance to make a substantial impact in the medical device sector.
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