Regulatory Affairs Team Leader
Paying up to £67,500
High Wycombe (2x days WFH 3x days Office)
Looking to work for a truly fantastic company that looks after their staff and where you are treated as an invividual all whilst working with amazing Medical Device products that are used all over the globe?
Keen to grow and develop in a newly created role where you will manage a team and be invovled in the coaching and developing of staff?
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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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: You will likely be asked to leave at 5pm to go home and enjoy your personal time, this company fosters a fantastic culture where your wellbeing is of utmost importance.
Here is an insight in what will be your day to day...
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External Collaboration: Work with external consultants on Clinical Evaluations as needed.
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Clinical Evidence: Identify, review, and summarise clinical evidence from various data sources for regulatory documents and post-market surveillance.
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Document Preparation: Prepare and review summaries, reports, and clinical documents to ensure regulatory compliance and support product registrations.
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Post-Market Activities: Participate in post-market and reimbursement activities across global markets, including the EU, USA, and Australia.
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PMCF Guidance: Provide direction on Post-Market Clinical Follow-up (PMCF) activities and contribute to surveillance plans.
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CE/UKCA Marking: Plan and deliver key documents for CE/UKCA marking under European Medical Device Regulations (MDR).
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Content Development: Research, write, and review clinical/scientific materials and regulatory documents, including clinical study protocols, reports, and submissions to regulatory bodies.
What we do need from you...
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At least four years of professional experience in a Regulatory & Clinical setting relating to medical devices, with a high regard for the technical aspects of the functions.
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Have experience of Line Management and task delegation.
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Have sound experience in scientific/medical writing (i.e., CER documentation) and be able to conduct clinical searches in relation to our products.
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Have a comprehensive knowledge of clinical evaluation guidelines and regulations (MEDDEV 2.7/1, EU MDR, MDCG guidelines).
Want to know more, apply today and let's chat