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Regulatory Affairs Specialist
2 months ago
We are seeking a highly skilled Regulatory Affairs & Quality Assurance Consultant to join our team at LFH Regulatory Limited. As a key member of our team, you will be responsible for managing client projects, creating regulatory strategies, and ensuring compliance with medical device regulations.
Key Responsibilities- Manage client projects, including onboarding new clients and creating regulatory strategies for global markets.
- Develop and maintain technical file documentation, including risk management, post-market surveillance, and essential requirements checklists.
- Register devices with regulatory authorities and review UK responsible person documentation.
- Liaise with Notified/Approved Bodies and Competent Authorities.
- Provide support to clients pre, during, and post-audit, including audit preparation and non-conformity assistance.
- Minimum of 3-5 years of experience in regulatory affairs and/or quality assurance within the medical device/IVD industry.
- Must be based in the UK.
- Willingness to learn and grow, with a strong problem-solving skillset and in-depth knowledge of medical device regulations and standards.
- Experience with device development, quality management systems, audits, technical documentation, risk management, and clinical requirements.
- Strong understanding of recalls and adverse event management, product registration, and UK Responsible Person requirements.
- Excellent communication and interpersonal skills, with the ability to work independently and as part of a team.
- Attention to detail and strong analytical skills, with relevant certifications or qualifications in regulatory affairs.
- Bachelor's degree or higher in a related field.
We offer a competitive salary and compensation package, including a salary of up to £60k pro rata depending on experience, company-based bonus scheme, and life insurance. You will also have the opportunity to work on a diverse range of projects, enhance your skills and broaden your knowledge in the field of medical device regulation, and contribute to the development of crucial regulatory documents that impact the advancement of medical technology.
As a member of our team, you will have the opportunity to work on a diverse range of projects, from writing and editing regulatory documents to providing oversight for outsourced deliverables to our clients. You will be able to enhance your skills and broaden your knowledge in the field of medical device regulation, and contribute to the development of crucial regulatory documents that impact the advancement of medical technology.
We are a top medical device consultancy company, and we are seeking a permanent Regulatory Affairs & Quality Assurance Consultant to join our team. We are open to full-time as well as part-time applicants between 3 to 5 days. If you are an experienced regulatory affairs and quality assurance professional looking for a new challenge, we have just the opportunity for you.