Clinical and Regulatory Affairs Manager
3 weeks ago
Position: Regulatory and Clinical Project Manager
Location: High Wycombe - Hybrid Work Model
Compensation: Up to £67,500 plus Benefits
Benefits of Joining Us:
- Meaningful Contributions: You will be instrumental in advancing innovative medical devices, ensuring compliance with stringent regulatory requirements and supporting clinical validation.
- Opportunities for Advancement: We provide a structured career progression plan, enabling you to lead significant projects and expand your responsibilities within the organization.
- Continuous Learning: Access to professional development initiatives, including training programs and industry conference participation, to enhance your regulatory and clinical acumen.
- Creative Work Environment: Collaborate with a diverse 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 options to support your personal and professional commitments.
Key Qualifications:
- Experience: At least 4 years in a Regulatory & Clinical environment within the medical device sector, with a strong emphasis on technical roles.
- Educational Background: A degree in law, medicine, pharmacy, engineering, or a related scientific field.
- Project Management Skills: Possession of PRINCE2 or an equivalent project management certification. A meticulous and detail-oriented approach to project management is essential.
- Writing Proficiency: Expertise 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 standards and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.
- Leadership Experience: Demonstrated capability in team management and task delegation.
Responsibilities:
- Project Leadership: Oversee regulatory and clinical initiatives, including submissions for MDR, 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 support to cross-functional teams.
- Clinical Management: Work with external consultants, perform literature reviews, and prepare essential regulatory documents such as Clinical Evaluation and Post Market Surveillance Reports.
Be part of a vibrant organization that values your expertise and is committed to your professional growth. This role offers a unique opportunity to make a significant impact in the medical device field.
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