Post-Market Surveillance Manager
5 days ago
Oxford Nanopore Technologies is a leading biotechnology company that specializes in the development of innovative sequencing technologies. Our company is headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations.
We are seeking a highly skilled and experienced Post-Market Surveillance Manager to join our Regulatory Affairs team. The successful candidate will be responsible for coordinating all post-market activities, ensuring compliance with regulatory requirements, and providing regular report updates to the Regulatory Affairs Manager and the wider business.
Key Responsibilities:- Post-Market Surveillance: Organize and coordinate post-market surveillance tasks aligned to our Quality Management System (QMS) policies, procedures, processes, and international regulations.
- Product Compliance: Ensure that the requirements of individual products Post Market Surveillance plans are met.
- Collaboration and Communication: Work closely with our technical services and external key strategic partners to ensure PMS information is captured, triaged, escalated, and completed appropriately.
- Investigations and Reporting: Coordinate cross-functional teams to ensure investigations that include detailed information gathering, analysis, and reporting are conducted and concluded satisfactorily.
- Customer Feedback and Reporting: Work with the Regulatory Affairs Manager to establish and maintain PMS information sources for actively gathering customer feedback, monitoring, and reporting of product field performance.
- Vigilance Reporting: Provide information in a timely manner to the Regulatory Affairs Manager for use in the development of any required vigilance reporting.
- Training and Development: Educate other members of staff in the requirements of PMS activities.
- Process Improvement: Work alongside the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes and propose process enhancement/improvements where necessary.
- Reporting and Presentations: Build PMS reports, with updates as required by those products PMS plans, and contribute to management review meetings through preparation and presentation of PMS information.
- Regulatory Experience: A good grounding in IVD device regulations, specifically post-market surveillance requirements, with several years' experience working in a regulatory affairs team within the diagnostics industry.
- Regulatory Knowledge: A strong and solid understanding of 21CFR, IVDR, and ISO 13485.
- Key Skills: Strong communication, excellent writing skills, effective team worker across multi-disciplinary teams, excellent analytical/problem-solving skills, strong persuasion skills, and ability to make and take decisions but also understanding of when to escalate.
- Attractive Bonus: A competitive bonus scheme.
- Generous Pension Contributions: A comprehensive pension plan.
- Private Healthcare: A private healthcare package.
- Excellent Starting Salary: A competitive salary package.
-
Post Market Surveillance Coordinator
1 week ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. Our company is headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.We employ a diverse...
-
Post-Market Surveillance Lead
4 weeks ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout Oxford Nanopore Technologies Oxford Nanopore Technologies is a pioneering company at the forefront of genomic analysis, with a commitment to innovation and excellence in the field of life sciences. Our headquarters are located in a dynamic environment, and we have a presence in various global markets, including the US, APAC, and Europe. Our team is...
-
Post-Market Surveillance Manager
5 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Post-Market Surveillance Manager
5 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Post Market Surveillance Manager
1 month ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeOxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and a commercial presence in many global locations across the US, APAC and Europe.Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics,...
-
Post Market Surveillance Coordinator
6 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered in the UK, with a global presence in multiple locations. Our company employs experts from various fields, including nanopore science, molecular biology, informatics, engineering, electronics, manufacturing, and commercialization.Our management team, led by CEO Dr....
-
Post Market Surveillance Coordinator
5 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered in the UK, with a global presence in multiple locations. Our company employs experts from various fields, including nanopore science, molecular biology, informatics, engineering, electronics, manufacturing, and commercialization.Our management team, led by CEO Dr....
-
Post Market Surveillance Coordinator
1 week ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. Our company is headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations.We employ a diverse team of experts from various...
-
Post-Market Surveillance Manager
6 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Post-Market Surveillance Manager
5 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Vigilance & Post Market Surveillance Manager
7 days ago
Oxford, UK, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeOxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and a commercial presence in many global locations across the US, APAC and Europe.Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics,...
-
Market Monitoring and Surveillance Manager
3 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.As a key member of the Regulatory Affairs team, this role will be responsible for coordinating all required post-market activities....
-
Market Monitoring and Surveillance Manager
3 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.As a key member of the Regulatory Affairs team, this role will be responsible for coordinating all required post-market activities....
-
Market Monitoring and Surveillance Coordinator
20 hours ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Market Monitoring and Surveillance Coordinator
22 hours ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications,...
-
Quality Assurance Manager
1 week ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. As a Post Market Surveillance Manager, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate post-market surveillance...
-
Regulatory Affairs Specialist
1 week ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. As a Post Market Surveillance Manager, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate post-market surveillance...
-
Senior Product Marketing Manager
4 days ago
Oxford, Oxfordshire, United Kingdom Market Recruitment Ltd Full timeJob OverviewThis is a newly created role where you will be responsible for the entire product marketing process for a key industry vertical.Key ResponsibilitiesStrategy Development: take the lead on strategic product marketing projects, ensuring alignment with the company's overall business objectives.Stakeholder Management: work with cross-functional teams,...
