Clinical Regulatory Affairs Manager
3 weeks ago
Regulatory and Clinical Project Manager
Location: High Wycombe - Hybrid (2 days remote post-probation)
Compensation: Up to £67,500 plus Benefits
Benefits of Joining Us:
- Meaningful Contributions: You will be instrumental in the launch of transformative medical devices, ensuring compliance with stringent regulatory standards and supporting clinical validation.
- Career Advancement: We provide a structured pathway for professional growth, with opportunities to spearhead significant projects and expand your role within the organization.
- Ongoing Education: Access to continuous training and development initiatives, including support for professional certifications and participation in industry events, keeping you at the forefront of regulatory and clinical knowledge.
- Creative Workplace: Collaborate with a skilled, diverse team in an organization that prioritizes innovation, creativity, and ongoing enhancement.
- Flexible Work Arrangements: We recognize the importance of work-life balance and offer adaptable working conditions to help you effectively manage your career and personal commitments.
Key Qualifications:
- Experience: At least 4 years in a Regulatory & Clinical environment within the medical device sector, emphasizing technical roles.
- Educational Background: Degree in law, medicine, pharmacy, engineering, or a related scientific field.
- Project Management Skills: PRINCE2 or a similar recognized project management certification. A meticulous and detail-oriented approach to project and timeline management is crucial.
- Writing Proficiency: Strong capabilities in scientific and medical documentation, particularly in Clinical Evaluation Reports (CER). Ability to conduct relevant clinical literature searches.
- Regulatory Expertise: Comprehensive knowledge of clinical evaluation regulations and guidelines, including MEDDEV 2.7/1, EU MDR, and MDCG directives.
- Leadership Experience: Demonstrated capability in team management and task delegation.
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 direction to cross-functional teams.
- Clinical Management: Work with external consultants, perform 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 development. This is an excellent opportunity to make a significant impact in the medical device sector.
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