Clinical Regulatory Project Leader
3 weeks ago
Regulatory and Clinical Project Manager
Location: Hybrid Work Environment
Compensation: Up to £67,500 plus Benefits
Benefits of Joining Us:
- Meaningful Contributions: You will be instrumental in facilitating the introduction of transformative medical devices, ensuring compliance with stringent regulatory standards and supporting clinical validation.
- Opportunities for Advancement: We provide a structured pathway for professional growth, allowing you to lead prominent projects and assume greater responsibilities within the organization.
- Continuous Learning: Access to ongoing training and development initiatives, including assistance with certifications and participation in industry events, to enhance your regulatory and clinical knowledge.
- Collaborative Culture: Engage with a skilled, multidisciplinary team in an organization that prioritizes innovation, creativity, and ongoing improvement.
- Flexible Work Arrangements: We recognize the importance of work-life balance and offer adaptable working conditions to support your personal and professional commitments.
Qualifications Required:
- Experience: At least 4 years in a Regulatory & Clinical capacity within the medical device sector, emphasizing technical expertise.
- 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 project oversight is essential.
- Writing Proficiency: Strong capabilities in scientific and medical documentation, particularly in Clinical Evaluation Reports (CER). Ability to conduct relevant clinical literature searches.
- Regulatory Acumen: Comprehensive knowledge of clinical evaluation guidelines and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.
- Leadership Experience: Demonstrated ability in team management and task delegation.
Key Responsibilities:
- Project Leadership: Oversee regulatory and clinical initiatives, including MDR submissions, new product launches, and international market registrations. Manage CAPAs and ensure project documentation is maintained.
- Regulatory Adherence: Maintain Medical Device Files, assist with regulatory audits, and provide guidance to cross-functional teams.
- Clinical Management: Collaborate with external consultants, conduct literature reviews, and prepare essential 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 development. This role offers a unique opportunity to make a substantial impact in the medical device sector.
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