Regulatory and Clinical Manager
Paying up to £67,500 plus Benefits
High Wycombe - Hybrid (2x a week at home after successful probation)
What’s In It for You?:
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Impactful Work: You'll play a critical role in bringing life-changing medical devices to market, ensuring they meet the highest regulatory standards and are backed by robust clinical evidence.
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Career Growth: We offer a clear path for career advancement, with opportunities to lead high-profile projects and take on more significant responsibilities within the organisation.
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Professional Development: You'll have access to ongoing training and development programs, including support for certifications and attendance at industry conferences, to keep you at the forefront of regulatory and clinical expertise.
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Innovative Environment: Work alongside a talented, multidisciplinary team in a company that values creativity, innovation, and continuous improvement.
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Work-Life Balance: We understand the importance of balance and offer flexible working arrangements to help you manage your professional and personal life effectively.
What we need from you!
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Experience: A minimum of 4 years in a Regulatory & Clinical setting within the medical device industry, with a strong focus on technical functions.
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Education: Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline.
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Writing Skills: Proficient in scientific and medical writing, particularly in Clinical Evaluation Reports (CER). Able to conduct clinical searches relevant to our products.
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Regulatory Knowledge: In-depth understanding of clinical evaluation guidelines and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.
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Leadership: Proven experience in line management and task delegation.
Some of what you will be doing...
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Project Management: Lead regulatory and clinical projects, including MDR submissions, new product introductions, and foreign market registrations. Manage CAPAs and maintain project documentation.
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Regulatory Compliance: Maintain Medical Device Files, support regulatory audits, and provide guidance to cross-functional teams.
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Clinical Oversight: Collaborate with external consultants, conduct literature reviews, and prepare regulatory documents like Clinical Evaluation and Post Market Surveillance Report
You’ll be part of a dynamic company that not only values your expertise but also invests in your future. If you're ready to make a significant impact in the medical device industry, this is the opportunity you've been waiting for. If you don't have an updated CV, just send us what you have!
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