Regulatory Affairs Specialist
4 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at LFH Regulatory Limited. As a key member of our team, you will be responsible for managing client projects and providing expert guidance on regulatory compliance.
Key Responsibilities- Develop and implement regulatory strategies for global markets, including classification of medical devices and IVDs.
- Create, maintain, and conduct gap assessments on technical file documentation for clients, including risk management, post-market surveillance, and essential requirements.
- Register devices with regulatory authorities and review and prepare UK responsible person documentation.
- Liaise with Notified/Approved Bodies and Competent Authorities.
- Provide support to clients pre, during, and post audit, including audit preparation, attending audits, and assisting with non-conformities.
- 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: We are looking for a motivated candidate who is eager to learn and grow as part of a team.
- Problem-solving skills: As a Senior Regulatory Consultant, you'll need to be a proactive problem solver.
- In-depth knowledge of medical device regulations and standards, including EU MDR, IVDR, and ISO 13485.
- 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.
- Ability to work independently and as part of a team.
- Attention to detail and strong analytical skills.
- Relevant certifications or qualifications in regulatory affairs.
- Bachelor's degree or higher in a related field.
- US FDA experience.
- Experience with Software as a Medical Device (SaMD).
- Implementation of full and partial quality management systems by creating/writing procedures, controlled forms, and work instructions.
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Regulatory Affairs Specialist
3 days ago
Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time £60,000About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist 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 ResponsibilitiesManage client projects, including onboarding new...
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Regulatory Affairs Specialist
3 days ago
Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time £60,000About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist 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 ResponsibilitiesManage client projects, including onboarding new...
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Regulatory Affairs Specialist
4 days ago
Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at LFH Regulatory Limited. As a key member of our team, you will be responsible for managing client projects and providing expert guidance on regulatory compliance.Key ResponsibilitiesManage client projects, including onboarding new clients and exploring new business...
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Regulatory Affairs Specialist
4 days ago
Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at LFH Regulatory Limited. As a key member of our team, you will be responsible for managing client projects and providing expert guidance on regulatory compliance.Key ResponsibilitiesManage client projects, including onboarding new clients and exploring new business...
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Regulatory Affairs Specialist
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeAre you a skilled professional in regulatory affairs and quality assurance seeking a new opportunity? Look no further.LFH Regulatory Limited is a leading consultancy in the medical device sector, currently in search of a Regulatory Affairs & Quality Assurance Consultant for a fixed-term engagement. This role offers the flexibility of remote work with...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time £60,000Job DescriptionJob Title: Regulatory Affairs & Quality Assurance ConsultantCompany: LFH Regulatory LimitedLocation: Remote (UK-based)Job Type: Full-timeContract: Fixed-term contract of 12 months with possible extensionJob SummaryWe are seeking a highly experienced Regulatory Affairs & Quality Assurance Consultant to join our dynamic team at LFH Regulatory...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time £60,000About the RoleWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist 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 providing support to clients in the medical device and IVD industry.Key ResponsibilitiesManage...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time £60,000About the RoleWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist 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 providing support to clients in the medical device and IVD industry.Key ResponsibilitiesManage...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeJob DescriptionLFH Regulatory Limited is seeking a highly experienced Regulatory Affairs and Quality Assurance Specialist to join our team on a fixed-term contract of 12 months with possible extension. As a leading medical device consultancy company, we work with various clients across the globe, offering a stimulating work environment and opportunities for...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeJob DescriptionLFH Regulatory Limited is seeking a highly experienced Regulatory Affairs and Quality Assurance Specialist to join our team on a fixed-term contract of 12 months with possible extension. As a leading medical device consultancy company, we work with various clients across the globe, offering a stimulating work environment and opportunities for...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time £60,000Job DescriptionLFH Regulatory Limited is seeking a highly skilled Regulatory Affairs & Quality Assurance Consultant to join our dynamic team. As a key member of our team, you will be responsible for managing client projects, providing regulatory strategies, and ensuring compliance with medical device regulations.Key Responsibilities:Manage client projects,...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeJob DescriptionRole OverviewWe are seeking a highly experienced Regulatory Affairs and Quality Assurance professional to join our team at LFH Regulatory Limited. As a Regulatory Affairs and Quality Assurance Consultant, you will be responsible for managing client projects, creating regulatory strategies, and ensuring compliance with medical device...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs and Quality Assurance professional to join our team at LFH Regulatory Limited. As a Senior Regulatory Consultant, you will play a key role in managing client projects, creating regulatory strategies, and ensuring compliance with medical device regulations.Key ResponsibilitiesManage client...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeAbout the RoleWe are seeking a highly experienced Regulatory Affairs and Quality Assurance professional to join our team at LFH Regulatory Limited. As a Senior Regulatory Consultant, you will play a key role in managing client projects, creating regulatory strategies, and ensuring compliance with medical device regulations.Key ResponsibilitiesManage client...
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Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full timeAre you a seasoned professional in regulatory affairs and quality assurance seeking a new opportunity? If so, we invite you to explore this role.LFH Regulatory Limited, a leading consultancy in the medical device sector, is in search of a Regulatory Affairs & Quality Assurance Consultant for a fixed-term contract. This position offers the flexibility of...
