Clinical and Regulatory Affairs Manager
3 weeks ago
Clinical and Regulatory Project Manager
Location: Hybrid Work Model
Compensation: Up to £67,500 plus Benefits
Why Consider This Role?:
- Meaningful Contributions: You will be instrumental in facilitating the launch of transformative medical devices, ensuring compliance with stringent regulatory requirements and substantiated clinical evidence.
- Opportunities for Advancement: We provide a structured pathway for professional growth, enabling you to lead significant projects and assume greater responsibilities within the organization.
- Continuous Learning: Access to ongoing training and development initiatives, including support for certifications and participation in industry conferences, will keep you at the forefront of regulatory and clinical knowledge.
- Collaborative Environment: Engage 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 options to help you effectively manage your professional and personal commitments.
Key Qualifications
- Professional Experience: At least 4 years in a Regulatory & Clinical capacity within the medical device sector, emphasizing technical roles.
- Educational Background: A degree in law, medicine, pharmacy, engineering, or a related scientific field.
- Project Management Expertise: PRINCE2 or another recognized project management certification is required. A meticulous, detail-oriented approach to project management is essential.
- Writing Proficiency: Strong skills in scientific and medical writing, particularly in Clinical Evaluation Reports (CER), along with the ability to conduct relevant clinical searches.
- Regulatory Acumen: Comprehensive knowledge of clinical evaluation guidelines and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.
- Leadership Skills: Demonstrated experience in managing teams and delegating tasks effectively.
Responsibilities Include:
- Project Leadership: Oversee regulatory and clinical projects, including submissions for MDR, new product launches, and international market registrations. Manage CAPAs and ensure thorough project documentation.
- Regulatory Oversight: 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.
Be part of a dynamic organization that values your expertise and is committed to investing in your professional journey. This role offers a unique opportunity to make a significant impact in the medical device field.
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