Senior Director Regulatory Affairs Lead
4 weeks ago
Oxford Nanopore Technologies is a leading developer of innovative sequencing technologies. Our headquarters are located at the Oxford Science Park, with satellite offices and commercial presence in various global locations. We employ experts from diverse fields, including nanopore science, molecular biology, informatics, engineering, electronics, manufacturing, and commercialization. Our management team, led by CEO Dr. Gordon Sanghera, has a track record of delivering disruptive technologies to the market.
Our MissionWe aim to enable the analysis of any living thing, by anyone, anywhere. Our real-time nanopore-based DNA/RNA sequencing technology is accessible, easy to use, and fully scalable for any requirement. We offer a range of products based on our unique and market-leading nanopore-based next-generation sequencing (NGS) technology. In addition to selling our technologies and products into research use only applications, we also market IVD instruments using the same highly complex, unique NGS technology.
Job SummaryWe are seeking a Senior Director Regulatory Affairs to join our team. The successful candidate will be responsible for ensuring the firm fully complies with its regulatory obligations, overseeing the operation and functions of the Regulatory Affairs team, and ensuring compliance with our Quality Management System (QMS). The role will involve managing the Regulatory, Risk Management, PMS, and Clinical Affairs functions, establishing strong working relationships across the business, and leading all Health Authority interactions and communications.
Key Responsibilities- Manage the Regulatory, Risk Management, PMS, and Clinical Affairs functions.
- Establish strong working relationships across the business to facilitate best practices in risk management, product development, testing, manufacture, and post-market surveillance of products.
- Lead all Health Authority interactions and communications (pre-submissions, submissions, recalls, etc.).
- Regularly monitor data outputs from functions with regulatory relevance, such as complaints and customer feedback.
- Provide regulatory input into the development and maintenance of Quality Systems to ensure compliance with regulatory requirements.
- Ensure the business is updated with regulatory expectations and intelligence.
- Ensure training on regulatory processes is developed and maintained and assigned appropriately.
- Establish and maintain an effective Post-Market Surveillance system to meet regulatory requirements.
- Provide regulatory support to internal and external audits and inspections.
- Support and progress the compilation of regulatory submissions.
- Provide regulatory support in the correct application of technical standards to meet regulatory requirements and industry best practices.
- Qualification to BSc level or higher in a relevant scientific subject area or proven experience in working in a relevant regulatory role.
- A minimum of 5 years' experience in a senior regulatory management role (with significant quality contribution/responsibility) in the IVD industry, with management responsibility for a team of >5. Specifically, this experience should include in-depth work with both complex instrumentation and IVD assays.
- Direct experience of assembling and submitting FDA 510k and CE Tech File (to IVDR) reviews.
- Detailed understanding of risk management, process validation, clinical validation, electrotechnical instrumentation compliance, and IVD V&V standards.
- Experience of working in an IVD environment along with practical experience in working to applicable standards (e.g., ISO 13485, ISO 14971, ISO 9001).
- Strong working knowledge of regulatory requirements applicable to IVD devices.
- Hands-on experience with leading teams to achieving compliance to at least two of the following: IEC 62304, IEC 62366, GLP, EMC.
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Regulatory Affairs Director
3 weeks ago
Oxford, Oxfordshire, United Kingdom https:jobs-redefined.cositemap Full timeSenior Director Regulatory AffairsOxford Nanopore Technologies is a leading developer of nanopore-based next-generation sequencing technology. The company is headquartered in the UK and has a global presence with offices and commercial operations in multiple locations across the US, APAC, and Europe.The Senior Director Regulatory Affairs will be responsible...
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Regulatory Affairs Director
3 weeks ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob SummaryOxford Nanopore Technologies is a leading developer of innovative DNA sequencing technologies. We are seeking a highly experienced Senior Director, Regulatory Affairs to join our team in Oxford, UK.The successful candidate will be responsible for ensuring the firm's compliance with regulatory requirements in the territories in which our IVD...
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Senior Director Regulatory Affairs Lead
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Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading developer of real-time nanopore-based DNA/RNA sequencing technology. Our goal is to enable the analysis of any living thing, by anyone, anywhere. We offer a range of products and services that cater to various needs, from research to clinical applications.Job SummaryWe are seeking a highly experienced Senior...
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Oxford, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading developer of innovative sequencing technologies. Our headquarters are located at the Oxford Science Park, with satellite offices and commercial presence in various global locations. Our team comprises experts from diverse fields, including nanopore science, molecular biology, informatics, engineering,...
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Oxford, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading developer of innovative sequencing technologies. Our headquarters are located at the Oxford Science Park, with satellite offices and commercial presence in various global locations. Our team comprises experts from diverse fields, including nanopore science, molecular biology, informatics, engineering,...
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Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading company in the field of sequencing technology, with a presence in multiple global locations. The company employs experts from various fields, including nanopore science, molecular biology, and informatics.The Senior Director of Regulatory Affairs will be responsible for ensuring the company's compliance with...
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Oxford, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading company in the field of nanopore-based DNA/RNA sequencing technology. Our goal is to enable the analysis of any living thing, by anyone, anywhere. We offer real-time nanopore-based DNA/RNA sequencing technology: accessible, easy to use and fully scalable for any requirement.Job SummaryWe are seeking a highly...
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Oxford, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading company in the field of nanopore-based DNA/RNA sequencing technology. Our goal is to enable the analysis of any living thing, by anyone, anywhere. We offer real-time nanopore-based DNA/RNA sequencing technology: accessible, easy to use and fully scalable for any requirement.Job SummaryWe are seeking a highly...
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Oxford, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading developer of innovative sequencing technologies. Our headquarters are located at the Oxford Science Park, with satellite offices and commercial presence in various global locations. Our management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.Our...
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Senior Director Regulatory Affairs
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Oxford, United Kingdom Oxford Nanopore Technologies Full timeAbout UsOxford Nanopore Technologies is a leading developer of innovative sequencing technologies. Our headquarters are located at the Oxford Science Park, with satellite offices and commercial presence in various global locations. Our management team, led by CEO Dr Gordon Sanghera, has a track record of delivering disruptive technologies to the market.Our...
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