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Regulatory and Clinical Project Manager

Up to £67,500

High Wycombe (2x Hybrid at home after successful probation)

What’s In It for You?

* 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!

* Experience: A minimum of 4 years in a Regulatory & Clinical setting within the medical device industry, with a strong focus on technical functions.

* Education: Degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline.

* Project Management: PRINCE2 or another recognized project management qualification. A disciplined, detail-oriented approach to managing projects and timelines is essential.

* Writing Skills: Proficient in scientific and medical writing, particularly in Clinical Evaluation Reports (CER). Able to conduct clinical searches relevant to our products.

* Regulatory Knowledge: In-depth understanding of clinical evaluation guidelines and regulations, including MEDDEV 2.7/1, EU MDR, and MDCG guidelines.

* Leadership: Proven experience in line management and task delegation.

Some of what you will be doing...

* Project Management: Lead regulatory and clinical projects, including MDR submissions, new product introductions, and foreign market registrations. Manage CAPAs and maintain project documentation.

* Regulatory Compliance: Maintain Medical Device Files, support regulatory audits, and provide guidance to cross-functional teams.

* 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 or call Charlotte on (phone number removed)